What's new in nuclear medicine
Approvals, label changes, pivotal trials and new guidelines since January 2024, newest first, each with what it changes in practice and its source. Check the current label and guideline before acting on any item.
FDA approves FET PET for glioma (Pixclara)
The FDA approved floretyrosine F 18 (18F-FET, Pixclara) to help separate recurrent or progressive glioma from treatment-related change. It is used with other diagnostic tests, in adults and in children from 1 month of age. It is the first FDA-approved amino acid PET agent for glioma; safety data came from 382 patients. US centres can now offer the amino acid PET on which the PET RANO 1.0 criteria are built.
Source: Telix Pharmaceuticals. FDA approves Telix's brain cancer imaging drug Pixclara [press release]. 14 Sep 2026.
Curium's 177Lu-dotatate approved as a Lutathera equivalent (Bexlutry)
The FDA approved Curium's lutetium Lu 177 dotatate (Bexlutry) for adults with SSTR-positive GEP-NETs, including foregut, midgut and hindgut tumours. It came through the 505(b)(2) pathway, with Lutathera as the reference product and bridging data showing similarity. The recommended cumulative activity is 29.6 GBq. US departments now have a second source of 177Lu-dotatate for adults; the adolescent indication remains Lutathera's alone.
Source: Curium. Curium announces FDA approval of BEXLUTRY lutetium Lu 177 dotatate injection for adults with SSTR-positive GEP-NETs [press release]. 14 Sep 2026.
Second tau PET agent approved: florquinitau F 18 (MK-6240, Tauklarify)
The FDA approved florquinitau F 18 (Tauklarify, formerly MK-6240) for brain PET in adults with cognitive impairment who are being evaluated for Alzheimer's disease. It identifies tau neurofibrillary tangle pathology. In two reader studies (279 and 338 subjects) positive agreement was 68–88% and negative agreement 93–99%. It is not established for non-Alzheimer tauopathies, and no commercial launch date has been given.
Source: Lantheus Holdings. Lantheus announces FDA approval of TAUKLARIFY (florquinitau F 18 injection), an F18-labeled tau PET imaging agent for Alzheimer's disease [press release]. 14 Aug 2026.
Pluvicto approved in PSMA-positive hormone-sensitive disease (PSMAddition)
The FDA approved 177Lu-PSMA-617 (Pluvicto) with an androgen receptor pathway inhibitor (ARPI) for PSMA-positive metastatic prostate cancer that is naive or sensitive to androgen pathway modulation. In PSMAddition (1144 patients) adding Pluvicto to ADT plus ARPI reduced radiographic progression or death (HR 0.72, 95% CI 0.58–0.90); overall survival data were immature. Grade ≥3 adverse events occurred in 51% vs 43%. The dose is 7.4 GBq every 6 weeks for up to six doses, after selection with Locametz or another approved PSMA PET agent.
Source: US Food and Drug Administration. FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naive or -sensitive prostate cancer. 31 Jul 2026. Tagawa ST, Sartor O, Piulats JM, et al. Lancet. 2026;408(10557):793-807.
EAU-EANM prostate cancer guidelines, 2026 update
The 2026 EAU-EANM-ESTRO-ESUR-ISUP-SIOG guidelines state that PSMA PET is the most sensitive technique for identifying metastatic spread. They introduce a new five-tier EAU risk classification. Part II covers relapsing and metastatic disease.
Source: Cornford P, et al. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer-2026 Update. Part I. Eur Urol. 2026;90(3):254-69.
COMPETE: 177Lu-edotreotide beats everolimus in GEP-NETs
COMPETE randomised 309 patients with progressive grade 1–2 GEP-NETs (2:1) to 177Lu-edotreotide (7.5 GBq every 3 months, up to four cycles) or everolimus. Median PFS was 23.9 vs 14.1 months (HR 0.67, 95% CI 0.48–0.95). Grade 3–4 treatment-related adverse events occurred in 18% vs 40%. The data support PRRT before everolimus. In August 2026 the FDA issued a complete response letter that cited manufacturing and third-party facility items, not efficacy or safety.
Source: Walter T, Jann H, Ansquer C, et al. Lancet. 2026;408(10551):234-47. ITM. ITM receives Complete Response Letter for 177Lu-edotreotide (ITM-11) [press release]. 10 Aug 2026.
EU: Pluvicto pre-chemotherapy extension withdrawn
Novartis withdrew its EU application to extend Pluvicto to taxane-naive, PSMA-positive mCRPC (the PSMAfore population). The CHMP doubted that the rPFS gain was meaningful and judged an ARPI switch an inadequate comparator. It also noted no effect on overall survival: final PSMAfore OS was 24.5 vs 23.1 months (HR 0.91), with 60% crossover. Pluvicto remains a post-taxane treatment in the EU, while the US label allows use before chemotherapy.
Source: European Medicines Agency. Pluvicto: withdrawal of application for variation to marketing authorisation. 23 Mar 2026. Fizazi K, Chi KN, Shore ND, et al. Ann Oncol. 2025;36(11):1319-30.
Lead-212 alpha PRRT: ALPHAMEDIX-02 phase 2 results
In ALPHAMEDIX-02, 212Pb-DOTAMTATE gave an objective response rate of 57.1% by central review in 35 PRRT-naive patients with SSTR-positive GEP-NETs. The rate was 19.2% in 26 patients previously treated with 177Lu-dotatate. The 36-month PFS rate in the naive cohort was 72.3%, and the commonest grade ≥3 event was lymphopenia. These are single-arm data; a phase 3 trial is planned and the agent is not approved.
Source: Sanofi. ESMO: AlphaMedix phase 2 data support first-in-class potential of new targeted alpha therapy in gastroenteropancreatic neuroendocrine tumors [press release]. 20 Oct 2025.
Procedure standards: post-therapy 177Lu imaging and flurpiridaz PET
SNMMI and ACNM advise SPECT/CT at about 24 hours after every 177Lu treatment, at the same time point each cycle. Single-time-point imaging is acceptable for clinical care; more time points give more accurate dosimetry. A companion multisociety standard covers 18F-flurpiridaz PET. It sets activities for rest, pharmacological and exercise stress, and list-mode acquisition for blood flow quantitation.
Source: Uribe C, et al. Summary: SNMMI/ACNM procedure standard for posttreatment imaging of 177Lu-based radiopharmaceuticals. J Nucl Med. 2025;66(10):1528-37. Packard RRS, et al. SNMMI/EANM/ASNC/ACNM procedure standard/practice guideline for 18F-flurpiridaz PET. J Nucl Med. 2025;66(10):1538-54.
ESC 2025: myocarditis and pericarditis, with a role for FDG PET
The first combined ESC guidelines on myocarditis and pericarditis introduce the term inflammatory myopericardial syndrome. Cardiac MRI is the central imaging test. 18F-FDG PET may be considered when MRI is inconclusive or contraindicated, particularly when cardiac sarcoidosis is suspected.
Source: Schulz-Menger J, et al. 2025 ESC Guidelines for the management of myocarditis and pericarditis. Eur Heart J. 2025;46(40):3952-4041.
North American paediatric administered activities: 2024 update
The Image Gently working group updated the 2016 North American guidelines; the update was approved in spring 2024. All 23 existing protocols remain, 9 are modified and 6 are new. The additions are 13N-ammonia and 82Rb for cardiac PET, 18F-DOPA, 68Ga-DOTATATE, 68Ga-DOTATOC and sodium iodide for thyroid cancer imaging. Five of the six new protocols are PET. Check local paediatric activity tables against them.
Source: Treves ST, Fahey FH, Ferrer Valencia V, et al. 2024 Update of the North American Consensus Guidelines for Pediatric Administered Radiopharmaceutical Activities. J Nucl Med Technol. 2025;53(3):193-7.
ATA 2025: fewer indications for radioiodine in DTC
The 2025 ATA guidelines use four recurrence-risk groups: low (under 10%), low-intermediate (10–15%), intermediate-high (16–30%) and high (over 30%). Remnant ablation is not recommended routinely in low-risk disease (strong recommendation). Adjuvant RAI may be considered in the two intermediate groups and is recommended in high-risk disease and distant metastases. rhTSH is preferred to hormone withdrawal, and a post-therapy scan should be done.
Source: Ringel MD, Sosa JA, Baloch Z, et al. 2025 American Thyroid Association Management Guidelines for Adult Patients with Differentiated Thyroid Cancer. Thyroid. 2025;35(8):841-985.
Amyloid PET labels now cover therapy selection, quantification and monitoring
The FDA expanded the flutemetamol F 18 (Vizamyl) label to adults with cognitive impairment. It now covers selection of patients for amyloid-targeting therapy, quantitative analysis of amyloid load, and monitoring of response to anti-amyloid treatment. FDA reviewers have since described labelling updates for amyloid PET drugs used to select patients for these therapies. Reports may now need a quantitative result as well as the visual read.
Source: GE HealthCare. FDA approves expanded indications for GE HealthCare's Vizamyl PET imaging agent for beta amyloid detection [press release]. 24 Jun 2025. Koo H, Mattay V, Hofling AA, et al. J Nucl Med. 2026;67:846-7.
IoN: no radioiodine ablation needed in low-risk DTC
IoN randomised 504 patients with low-risk differentiated thyroid cancer (pT1–T2, N0 or Nx) after total thyroidectomy to radioiodine ablation or no ablation. Five-year recurrence-free survival was 97.9% without ablation and 96.3% with it, meeting non-inferiority. Only 17 recurrences occurred. The result supports omitting ablation in this group, as the 2025 ATA guidelines now advise.
Source: Mallick U, et al. Thyroidectomy with or without postoperative radioiodine for patients with low-risk differentiated thyroid cancer in the UK (IoN). Lancet. 2025;406(10498):52-62.
PEACE-3: radium-223 plus enzalutamide, with bone protection
EORTC PEACE-3 randomised 446 men with bone-metastatic mCRPC to enzalutamide with or without six cycles of 223Ra. Median rPFS was 19.4 vs 16.4 months (HR 0.69), and interim OS was 42.3 vs 35.0 months (HR 0.69). Fractures occurred in 24.3% vs 13.4%, and bone-protecting agents became mandatory during the trial. If 223Ra is combined with enzalutamide, give denosumab or zoledronic acid.
Source: Tombal B, Choudhury A, Saad F, et al. Enzalutamide plus radium-223 in metastatic castration-resistant prostate cancer: results of the EORTC 1333/PEACE-3 trial. Ann Oncol. 2025;36(9):1058-67.
First FDA-cleared blood test for Alzheimer amyloid pathology
The FDA cleared the Lumipulse G pTau217/β-amyloid 1-42 plasma ratio for adults aged 55 or over with cognitive decline. In 499 patients the positive predictive value was 91.7% and the negative predictive value 97.3%, with under 20% indeterminate results. Roche announced FDA clearance of its Elecsys pTau217 test on 24 August 2026. Amyloid PET is likely to be used more for indeterminate results, treatment decisions and monitoring.
Source: US Food and Drug Administration. FDA clears first blood test used in diagnosing Alzheimer's disease [press release]. 16 May 2025. Roche Diagnostics. Elecsys pTau217 FDA clearance [press release]. 24 Aug 2026.
FDA: Pluvicto before chemotherapy (PSMAfore)
The FDA extended Pluvicto to PSMA-positive mCRPC after an ARPI, in patients considered appropriate to delay chemotherapy. In PSMAfore, rPFS improved against an ARPI switch (HR 0.41; updated median 11.6 vs 5.6 months). Overall survival did not differ significantly (HR 0.91), with most control patients crossing over. The company estimates the change roughly triples the eligible population.
Source: Novartis. FDA approves Novartis radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer [press release]. 28 Mar 2025.
Gozellix: a longer-lived 68Ga-PSMA-11 kit
Telix announced FDA approval of Gozellix, a new kit for gallium Ga 68 gozetotide (68Ga-PSMA-11). Its indications match existing PSMA PET agents: suspected metastasis before definitive therapy, and suspected recurrence with a rising PSA. The company cites a shelf life of up to six hours, which extends the distance a dose can travel.
Source: Telix Pharmaceuticals. FDA approves new prostate cancer imaging agent Gozellix [press release]. 21 Mar 2025.
Updated appropriate use criteria for amyloid PET, and the first for tau PET
The Alzheimer's Association and SNMMI rated 17 clinical scenarios. Amyloid PET was appropriate in 7, uncertain in 2 and rarely appropriate in 8. Tau PET, assessed for the first time, was appropriate in 5, uncertain in 6 and rarely appropriate in 6. The criteria are written for the era of anti-amyloid therapy.
Source: Rabinovici GD, et al. Updated appropriate use criteria for amyloid and tau PET: a report from the Alzheimer's Association and Society for Nuclear Medicine and Molecular Imaging Workgroup. Alzheimers Dement. 2025;21(1):e14338.
Joint guideline on PET for brain metastases
EANM, EANO, RANO and SNMMI issued version 1.0 of a practice guideline for PET in brain metastases. Amino acid PET, and to a lesser extent 18F-FDG, is valued mainly for separating recurrent metastases from treatment-related change. It gives a common protocol for departments that already offer glioma amino acid PET.
Source: Verger A, et al. Joint EANM/EANO/RANO/SNMMI practice guideline/procedure standard for PET imaging of brain metastases: version 1.0. Eur J Nucl Med Mol Imaging. 2025;52(5):1822-39.
First procedure standard for FAP PET
SNMMI and EANM published the first procedure standard for fibroblast activation protein (FAP) PET. It states that there are no approved clinical indications yet. Suggested activities are 100–200 MBq for 68Ga agents and 175–275 MBq for 18F agents, with uptake times of 20–60 and 30–90 minutes. Benign uptake is common, for example in osteoarthritis and fibrosis.
Source: Hope TA, et al. SNMMI Procedure Standard/EANM Practice Guideline for Fibroblast Activation Protein (FAP) PET. J Nucl Med. 2025;66(1):26-33.
ECLIPSE: 177Lu-PSMA-I&T meets its primary endpoint
Curium reported that ECLIPSE met its primary endpoint. 177Lu-PSMA-I&T (7.4 GBq every 6 weeks, up to six doses) improved rPFS against an ARPI switch in PSMA-positive mCRPC after an ARPI and before taxanes. The announcement gave no numerical results. With PSMAfore and SPLASH, it is the third positive phase 3 trial of a 177Lu-PSMA ligand before chemotherapy.
Source: Curium. Curium announces ECLIPSE trial has met primary endpoint [press release]. 13 Nov 2024.
Long-axial-field-of-view PET: workflow consensus
Twenty-eight experts from six countries agreed workflows for long-axial-field-of-view (LAFOV) PET/CT. These cover routine, dynamic, low-activity, fast, prolonged, delayed and dual-tracer imaging, plus reconstruction and installation. In November 2025 GE HealthCare gained a CE mark for a 128 cm total-body system, which it states is not FDA cleared. LAFOV systems let departments trade sensitivity for lower activity, shorter scans or whole-body dynamic imaging.
Source: Liu G, et al. Expert consensus on workflow of PET/CT with long axial field-of-view. Eur J Nucl Med Mol Imaging. 2025;52(3):1038-49. GE HealthCare. CE mark for Omni 128cm total-body PET/CT [press release]. 28 Nov 2025.
Medicare pays separately for high-cost diagnostic radiopharmaceuticals
CMS finalised separate outpatient payment, from 1 January 2025, for diagnostic radiopharmaceuticals costing more than $630 per day, paid at mean unit cost. Before this, they were bundled into the nuclear medicine procedure payment. The same rule set a $10 per-dose add-on, from 1 January 2026, for Tc-99m derived from domestically produced Mo-99. The change improves US access to high-cost PET agents.
Source: Centers for Medicare and Medicaid Services. CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System final rule (CMS-1809-FC) [fact sheet]. 1 Nov 2024.
99Mo shortage after the Petten reactor fails to restart
The High Flux Reactor at Petten did not restart on 10 October 2024 because a pipe above the reactor vessel had deformed. The MARIA and BR2 reactors were also offline. SNMMI warned of up to a 50% cut in 99Mo/99mTc supply; the reactor restarted on 4 November, and supply was expected to be normal from 11 November. Keep a written shortage plan that triages 99mTc studies and lists PET alternatives.
Source: SNMMI. Imminent Mo-99/Tc-99m shortage due to European reactor restart delay. Updates 19 and 30 Oct 2024. Authority for Nuclear Safety and Radiation Protection (ANVS). High Flux Reactor at Petten temporarily shut down. 22 Oct 2024.
EANM/SNMMI FDG PET in infection and inflammation, version 2.0
The joint guideline for 18F-FDG hybrid PET in infection and inflammation in adults replaces the 2013 version. It reports diagnostic performance for each indication from systematic reviews and meta-analyses up to January 2023. Use it as the reference for indications, patient preparation and reporting.
Source: Abikhzer G, et al. EANM/SNMMI guideline/procedure standard for [18F]FDG hybrid PET use in infection and inflammation in adults v2.0. Eur J Nucl Med Mol Imaging. 2025;52(2):510-38.
Flurpiridaz F 18 (Flyrcado) for PET myocardial perfusion
The FDA approved flurpiridaz F 18 (Flyrcado) for PET myocardial perfusion imaging at rest or stress in adults with known or suspected coronary artery disease. It is the first FDA-approved 18F-labelled PET perfusion agent. Its 109-minute half-life allows delivery from a regional cyclotron, so sites need neither a generator nor an on-site cyclotron, and exercise stress is possible.
Source: GE HealthCare. GE HealthCare announces FDA approval of Flyrcado (flurpiridaz F 18) injection PET radiotracer [press release]. 27 Sep 2024.
PSMAfore: 177Lu-PSMA-617 before taxanes
PSMAfore randomised 468 taxane-naive patients with PSMA-positive mCRPC, who had progressed once on an ARPI, to 177Lu-PSMA-617 or an ARPI switch. Median rPFS was 9.3 vs 5.6 months (HR 0.41), and 11.6 vs 5.6 months at the updated analysis. Grade 3–5 adverse events were less common with Lu-PSMA (36% vs 48%). Crossover was allowed, which later confounded overall survival.
Source: Morris MJ, Castellano D, Herrmann K, et al. Lancet. 2024;404(10459):1227-39.
SPLASH: 177Lu-PNT2002 before chemotherapy
SPLASH randomised 412 patients (2:1) with PSMA-positive mCRPC after one ARPI to 177Lu-PNT2002 (6.8 GBq every 8 weeks, four cycles) or an ARPI switch. Median rPFS was 9.5 vs 6.0 months (HR 0.71, 95% CI 0.55–0.92). Overall survival was immature: unadjusted HR 1.11 at 46% of events, and 0.68–0.85 after adjustment for crossover. As with PSMAfore, the survival benefit of pre-chemotherapy use is unproven.
Source: Lantheus Holdings. Lantheus presents results from the primary analysis of phase 3 pivotal SPLASH trial in PSMA-positive metastatic castration-resistant prostate cancer during ESMO Congress 2024 [press release]. 15 Sep 2024.
UpFrontPSMA: Lu-PSMA before docetaxel in hormone-sensitive disease
UpFrontPSMA randomised 130 men with de novo high-volume metastatic hormone-sensitive prostate cancer. They had two cycles of 177Lu-PSMA-617 (7.5 GBq) followed by docetaxel, or docetaxel alone. Undetectable PSA at 48 weeks was 41% vs 16% (OR 3.88), without more toxicity. It was the first randomised signal for Lu-PSMA in hormone-sensitive disease.
Source: Azad AA, Bressel M, Tan H, et al. Lancet Oncol. 2024;25(10):1267-76.
ESC 2024 chronic coronary syndromes: where MPI fits
The 2024 ESC guidelines add risk factors to the pre-test likelihood model, to find patients with very low (≤5%) likelihood of obstructive disease. CT coronary angiography is preferred to rule out obstructive disease. Functional imaging is preferred to link symptoms to ischaemia, assess viability and guide revascularisation. PET is preferred for absolute myocardial blood flow, with CMR perfusion as an alternative.
Source: Vrints C, et al. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024;45(36):3415-537.
Donanemab approved: amyloid PET before and during treatment
The FDA approved donanemab (Kisunla) for early symptomatic Alzheimer's disease, meaning mild cognitive impairment and mild dementia. The label requires amyloid pathology to be confirmed before treatment starts. It also advises considering stopping once amyloid plaques fall to minimal levels on amyloid PET. Amyloid PET therefore helps both to select patients and to decide when to stop.
Source: US Food and Drug Administration. FDA Roundup: July 2, 2024. Kisunla (donanemab-azbt) prescribing information. Eli Lilly and Company; 2024.
NETTER-2: first-line 177Lu-dotatate for higher-grade GEP-NETs
NETTER-2 randomised 226 patients with newly diagnosed, SSTR-positive, well-differentiated grade 2 (Ki-67 10–20%) or grade 3 (Ki-67 over 20% to 55%) GEP-NETs. They received 177Lu-dotatate plus octreotide LAR 30 mg, or octreotide LAR 60 mg. Median PFS was 22.8 vs 8.5 months (HR 0.28). Consider PRRT at diagnosis for this group.
Source: Singh S, Halperin D, Myrehaug S, et al. Lancet. 2024;403(10446):2807-17.
EANM-SNMMI guideline: FDG PET/CT in breast cancer
The joint guideline gives 18F-FDG PET/CT a role in baseline staging of no-special-type breast cancer from stage IIB to stage IV. Response should be reported with PERCIST, EORTC PET or EANM immunotherapy criteria, as appropriate.
Source: Vaz SC, et al. Joint EANM-SNMMI guideline on the role of 2-[18F]FDG PET/CT in no special type breast cancer. Eur J Nucl Med Mol Imaging. 2024;51(9):2706-32.
Lutathera approved for adolescents
The FDA approved 177Lu-dotatate (Lutathera) for patients aged 12 and over with SSTR-positive GEP-NETs. It was the first radiopharmaceutical approved for this paediatric group. Approval rested on NETTER-P dosimetry and safety data (9 patients, 4 with GEP-NETs) and extrapolation of NETTER-1 efficacy. The regimen is the adult one: 7.4 GBq every 8 weeks for four doses.
Source: US Food and Drug Administration. FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS. 23 Apr 2024.
ENZA-p: Lu-PSMA plus enzalutamide in first-line mCRPC
ENZA-p randomised 162 men with mCRPC and risk factors for early progression to enzalutamide alone or with 177Lu-PSMA-617. Lu-PSMA (7.5 GBq) was given as two or four doses, depending on an interim PSMA PET at 12 weeks. PSA progression-free survival was 13.0 vs 7.8 months (HR 0.43), with similar grade 3–5 events (40% vs 41%). A later substudy reported an overall survival benefit and found baseline PSMA tumour volume predictive of it.
Source: Emmett L, Subramaniam S, Crumbaker M, et al. Lancet Oncol. 2024;25(5):563-71. Emmett L, Papa N, Subramaniam S, et al. Lancet Oncol. 2025;26(9):1168-77.
Azedra (131I-MIBG) no longer made
No Azedra (high-specific-activity iobenguane I 131) has been manufactured since 1 March 2024. Lantheus had announced in August 2023 that it would discontinue production. It was the only FDA-approved radiopharmaceutical therapy for MIBG-avid phaeochromocytoma and paraganglioma. Options now include 177Lu-dotatate for SSTR-positive tumours and clinical trials.
Source: Lantheus Holdings, Inc. Form 10-Q for the quarterly period ended March 31, 2024. US Securities and Exchange Commission; 2024.
PET RANO 1.0: response criteria for amino acid PET in glioma
The RANO group published PET RANO 1.0, the first standard framework for amino acid PET response assessment in diffuse gliomas. It defines baseline and follow-up time points and response criteria for clinical trials. It is intended to move amino acid PET towards routine use. The 2026 US approval of FET PET makes it relevant in the US as well.
Source: Albert NL, Galldiks N, Ellingson BM, et al. PET-based response assessment criteria for diffuse gliomas (PET RANO 1.0): a report of the RANO group. Lancet Oncol. 2024;25(1):e29-e41.