OncoMatch/Clinical Trials/NCT06395402
177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
Is NCT06395402 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lutetium Lu 177 dotatate therapy for neuroendocrine tumors.
Treatment: Lutetium Lu 177 dotatate therapy — The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. To investigate this, study participants will: * Undergo Somatostatin Receptor (SSTR) positron emission tomography (PET) imaging, such as a DOTATOC PET/CT scan * Be randomized to receive standard treatment (as per FDA guidelines) or investigational treatment (customized dosing of Lutathera based upon dosimetry) * Undergo blood tests for 4 to 8 weeks after each Lutathera treatment * Complete patient reported outcome questionnaires * Visit the clinic for follow-up about every 8 weeks.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Required: SSTR2 uptake > liver background on sstr2 PET/CT (uptake > liver background)
uptake > liver background on sstr2 PET/CT with any FDA approved sstr2 imaging agent
Disease stage
Grade: 12 (who)
Performance status
ECOG OR KARNOFSKY 0–1
Prior therapy
Cannot have received: peptide-receptor radiotherapy
Prior peptide-receptor radiotherapy (PRRT)
Cannot have received: external beam radiation to kidneys >10 Gy (mean dose to functional renal volume)
Prior external beam radiation dose to the kidneys of >10 Gy (mean dose to functional renal volume)
Cannot have received: external beam radiation (including brachytherapy) involving 25% of the bone marrow (excluding scatter doses of ≤ 5 Gy)
Prior external beam radiation (including brachytherapy) involving 25% of the bone marrow (excluding scatter doses of ≤ 5 Gy) as estimated by a radiation oncologist
Lab requirements
Blood counts
Neutrophil count within normal limits within 28 days of treatment day 1. Platelet count within normal limits within 28 days of treatment day 1.
Neutrophil count within normal limits within 28 days of treatment day 1. Platelet count within normal limits within 28 days of treatment day 1.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Holden Comprehensive Cancer Center at the University of Iowa · Iowa City, Iowa
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify