An automated pheochromocytoma and paraganglioma lesion segmentation AI-model at whole-body 68Ga- DOTATATE PET/CT.
Fahmida Haque, Jorge A Carrasquillo, Evrim B Turkbey...
https://pubmed.ncbi.nlm.nih.gov/39500789Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 100Years
All Genders
ID04086485
Phase I/II Study of Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)
Led by National Cancer Institute (NCI) · Updated on 2026-05-22
56
Participants Needed
1
Research Sites
26 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying neuroendocrine tumors (NETs), a rare type of tumor found in the gastrointestinal tract and pancreas that cannot be cured by surgery. This trial evaluates whether a combination of two drugs, Lutathera (Lu-177-DOTATATE) and Olaparib, can be safely taken together without severe side effects and if this treatment can shrink the tumors. The study includes adults 18 years and older with somatostatin receptor-positive tumors confirmed by PET scans. Participants receive Lutathera through an intravenous infusion every 8 weeks for a total of 4 cycles, with each cycle lasting 8 weeks. Olaparib is taken orally twice daily for 4 weeks during each cycle. The study has two phases: Phase 1 to find the maximum tolerated dose of Olaparib when combined with Lutathera, and Phase 2 to evaluate the best overall response at that dose. Additional supportive treatments, like an amino acid infusion for kidney protection, are given during Lutathera administration. During the trial, participants undergo physical exams, blood and urine tests, heart function tests, and imaging scans of the chest, abdomen, and pelvis using specialized PET scans. They complete questionnaires about their health and well-being and keep a medicine diary to track Olaparib doses. Follow-up visits occur about 4 weeks after treatment ends, then every 12 weeks for 3 years, followed by yearly phone calls. Researchers monitor tumor response, safety, and overall health throughout the study.
CONDITIONS
Brief Title
Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of gastroenteropancreatic neuroendocrine tumor confirmed by tissue analysis
- Disease that cannot be treated by surgery (inoperable, metastatic, or locally advanced)
- Age 18 years or older
- Presence of somatostatin receptor positive disease confirmed by Ga-68-DOTATATE PET scan within 12 weeks
- ECOG performance status of 0 or 1
- Normal organ and bone marrow function as defined by specific lab values
- On consistent somatostatin analogue therapy for at least 3 months if applicable
- Willingness and ability to sign informed consent
- Postmenopausal or non-childbearing status with appropriate contraception if of childbearing potential
- Ability to comply with study procedures and follow-up
You will not qualify if you...
- Tumor lesions that are negative on Ga-68-DOTATATE PET but positive on FDG-PET unless progressed on prior treatment
- Breastfeeding mothers
- Other active cancers except certain treated skin or cervical cancers
- Use of investigational agents or systemic chemotherapy/radiotherapy within 4 weeks prior to enrollment
- Persistent moderate or worse toxicities from previous cancer treatments
- Weight over 400 lbs exceeding PET table limits
- Uncontrolled illnesses including infections, heart failure, unstable angina, high blood pressure, arrhythmias, or psychiatric conditions
- Symptomatic or uncontrolled brain metastases
- Spinal cord compression without stable disease
- Use of strong or moderate CYP3A inhibitors or inducers within specified timeframes
- Recent major surgery within 4 weeks
- Inability to swallow oral medication
- Previous allogeneic stem cell transplant
- Known allergy to study drugs or their components
- Uncontrolled cardiac conditions or congenital long QT syndrome
- Blood disorders like myelodysplastic syndrome or leukemia
- Immunocompromised status including HIV on antiretroviral therapy
- Active hepatitis B or C infection
- Prior treatment with PARP inhibitors or systemic radionuclide agents
- Involvement in planning or conduct of the study
- Previous treatment with Lu-177-DOTATATE
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for baseline assessments including Ga-68-DOTATATE PET scan and FDG-PET scan
Treatment
Duration - Approximately 32 weeks (4 cycles of 8 weeks each)
Participants receive up to 4 cycles of Lu-177-DOTATATE infusions combined with daily olaparib pills, starting 2 days before each Lu-177-DOTATATE dose and continuing for 4 weeks after each infusion. Each cycle lasts about 8 weeks.
4 infusions of Lu-177-DOTATATE every 8 weeks with continuous olaparib dosing; NIH clinic visits every 4 weeks; phone calls within a week after each Lu-177-DOTATATE infusion for toxicity assessment
Safety End of Treatment Visit
Duration - 1 visit occurring about 1 month after treatment completion
Participants attend a safety visit approximately 30 days after the last dose to assess treatment effects and overall safety.
1 visit (in-person)
Follow-up
Duration - Up to 3 years after end of treatment
Participants continue follow-up visits every 12 weeks for up to 3 years to monitor health status and disease progression, including periodic imaging scans.
Clinic visits every 12 weeks with imaging scans at week 32 and every 24 weeks thereafter
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
J
Joy H Zou, R.N.
F
Frank I Lin, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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