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DRUG:

Lutathera (lutetium Lu 177 dotatate)

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Other names: octreotate Lu-177 DOTA Tyr-3, 177Lu-[DOTA0, Tyr3] octreotate, [Lu-177]-DOTATATE, Lu-DOTATATE, 177Lu-DOTA-Octreotate, 177Lu-DOTA-tyr3-Octreotate, AAA601, 177Lu-DOTA0-Tyr3-octreotate, 177Lu-DOTATATE, [Lu-177]-Dota-Tyr3-Octreotate, AAA 601, AAA-601, [177Lu]Lu-DOTA-TATE
Company:
Novartis
Drug class:
Beta radiation emitter, SSTR2 modulator
Related drugs:
1d
Using Novel Imaging to More Safely Treat Neuroendocrine Tumors (clinicaltrials.gov)
P1, N=4, Completed, University of Wisconsin, Madison | Recruiting --> Completed | N=10 --> 4
Trial completion • Enrollment change
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SSTR (Somatostatin Receptor)
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SSTR positive
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Lutathera (lutetium Lu 177 dotatate)
1d
Emergency Appendectomy during the Early Phase after 177Lu-DOTATATE Therapy: A Case Report with Perioperative Radiation Safety after PRRT. (PubMed, Surg Case Rep)
This case demonstrates that emergency surgery can be performed safely during the early phase after PRRT when appropriate radiation safety precautions are implemented. Radiation exposure to surgical staff remained minimal at typical working distances, and even near-field exposure was within acceptable limits. Urgent surgical intervention should not be unnecessarily delayed following PRRT when clinically indicated, provided that appropriate monitoring and precautions are in place.
Journal
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SSTR (Somatostatin Receptor)
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SSTR positive
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Lutathera (lutetium Lu 177 dotatate)
1d
Preliminary Evaluation of 225Ac/177Lu-DOTATATE PRRT in Progressive Meningiomas: Efficacy, Dosimetry, and Imaging Insights. (PubMed, Clin Nucl Med)
Combined PRRT with 225Ac/177Lu-DOTATATE appears feasible and potentially beneficial option in advanced meningiomas. However, given the small sample size, treatment heterogeneity, and lack of controlled comparison, the findings should be interpreted with caution. Larger prospective studies are warranted.
Journal
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SSTR (Somatostatin Receptor)
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Lutathera (lutetium Lu 177 dotatate)
7d
Fraction-dependent dose dynamics and clinical safety in high-risk neuroblastoma treated with [177Lu]Lu-DOTATATE: results from the LuDO-N trial. (PubMed, Eur J Nucl Med Mol Imaging)
These findings support a front-loaded 177Lu-DOTATATE strategy to maximise tumour irradiation while maintaining exposure to risk organs within safety limits. Accordingly, the LuDO-N protocol has been amended to increase administered activity to 400 MBq/kg in the first fraction for subsequent patients. Together, this work contributes to the ongoing optimisation of dosimetry-guided and intensified treatment strategies for SSTR-targeted molecular radiotherapy for high-risk neuroblastoma.
Journal
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SSTR (Somatostatin Receptor)
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Lutathera (lutetium Lu 177 dotatate)
10d
Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors (clinicaltrials.gov)
P1, N=29, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Dec 2026 | Trial primary completion date: Jun 2026 --> Dec 2026
Trial completion date • Trial primary completion date
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peposertib (M3814) • Lutathera (lutetium Lu 177 dotatate)
15d
Feasibility of treating neuroendocrine prostate cancer with anti-SSTR radioligands: A systematic review of imaging and treatment studies. (PubMed, Semin Nucl Med)
SSTR expression in NEPC is heterogeneous. SSTR imaging can support phenotyping and selection for SSTR directed therapy in selected patients, including PSMA low disease, but prospective validation with standardized reporting is needed.
Review • Journal
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SSTR (Somatostatin Receptor)
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Lutathera (lutetium Lu 177 dotatate)
16d
High Somatostatin Receptor Expression in Alveolar Soft Part Sarcoma Detected by 68Ga-DOTATOC PET/CT. (PubMed, Clin Nucl Med)
DOTATOC PET showed no uptake in the pancreatic lesion but revealed high uptake in the primary ASPS in scapula and previously unrecognized metastases in the breast and skull, indicating high somatostatin receptor (SSTR) expression. To our knowledge, this is the first report of DOTATOC uptake in ASPS, which raises the prospect of SSTR-targeted treatment with 177Lu-DOTATATE.
Journal
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SSTR (Somatostatin Receptor)
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Lutathera (lutetium Lu 177 dotatate)
18d
Update on PET Imaging of Neuroendocrine Neoplasms. (PubMed, Semin Ultrasound CT MR)
Hybrid PET/MRI improves hepatic lesion characterization and reduces radiation in appropriate patients, while CT/MRI remains indispensable for morphology and complications. Integrating multi-tracer PET with anatomic imaging refines risk stratification, PRRT selection, and longitudinal response assessment.
Review • Journal
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CXCR4 (Chemokine (C-X-C motif) receptor 4) • SSTR (Somatostatin Receptor)
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Lutathera (lutetium Lu 177 dotatate)
20d
177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer (clinicaltrials.gov)
P2, N=10, Recruiting, OHSU Knight Cancer Institute | Not yet recruiting --> Recruiting | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2026 --> Dec 2027
Enrollment open • Trial completion date • Trial primary completion date
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PD-L1 (Programmed death ligand 1) • SSTR (Somatostatin Receptor)
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HR positive
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Lutathera (lutetium Lu 177 dotatate)
21d
ReLUTH: Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET (clinicaltrials.gov)
P2, N=146, Recruiting, Institut du Cancer de Montpellier - Val d'Aurelle | Trial completion date: Oct 2031 --> Oct 2033 | Trial primary completion date: Oct 2031 --> Oct 2033
Trial completion date • Trial primary completion date
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SSTR (Somatostatin Receptor)
|
Lutathera (lutetium Lu 177 dotatate)
21d
Long-term toxicity of tandem radioligand therapy using [90Y]Y/[177Lu]Lu-DOTA-TATE in neuroendocrine tumors: a polish multicenter experience with 20-year follow-up. (PubMed, Eur J Nucl Med Mol Imaging)
Tandem RLT was associated with low rates of severe late toxicity, even after very prolonged follow-up and repeated treatment courses, although gradual long-term decline in renal function was common. These data provide a rare long-term real-world benchmark for late toxicity of high-energy β-emitter-based RLT and support the long-term feasibility of tandem RLT in selected patients with NETs.
Journal
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SSTR (Somatostatin Receptor)
|
Lutathera (lutetium Lu 177 dotatate)
23d
[177Lu]Lu-dota-tate versus sunitinib in patients with metastatic progressive neuroendocrine tumours of the pancreas (OCLURANDOM): a randomised, controlled, phase 2 trial. (PubMed, Lancet Oncol)
Using sunitinib as an internal control, our results show clinically significant antitumour efficacy of [177Lu]Lu-dota-tate in pretreated, progressive, somatostatin receptor-positive, metastatic pancreatic neuroendocrine tumours, and a better quality of life during the treatment phase. Late adverse events were reported in the [177Lu]Lu-dota-tate group that might affect the tolerance of subsequent lines of treatment.
P2 data • Journal
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SSTR (Somatostatin Receptor)
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SSTR positive
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sunitinib • Lutathera (lutetium Lu 177 dotatate)