Actively Recruiting
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
Led by Methodist Health System · Updated on 2026-03-20
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the characteristics, treatment responses, survival outcomes, and side effects of Peptide Receptor Radionuclide Therapy (PRRT) in patients with gastroenteropancreatic primary neuroendocrine tumors (NETs). This observational study aims to gather detailed clinical data to better understand how this therapy works for advanced NETs, especially given the significant number of patients presenting with or developing metastatic disease. The study involves patients treated with PRRT as decided by their doctors, focusing on those with metastatic or locally advanced, inoperable tumors that have shown disease progression despite prior therapy. Treatment details include molecular therapy using radioisotopes targeting NETs, with data collected over a seven-year period to evaluate tumor responses, survival, imaging findings, biomarkers, and adverse events. Participants will have their demographics, tumor specifics, biomarker levels, imaging results, survival rates, time to progression, treatment responses, disease progression, and side effects tracked for seven years from the date of their procedure. The study requires patients to consent and comply with study protocols, including signing informed consent in English, and aims to provide comprehensive long-term monitoring of the effects and outcomes related to PRRT treatment.
CONDITIONS
Brief Title
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Diagnosed with gastroenteropancreatic primary neuroendocrine tumor and consented to undergo PRRT as decided by the treating physician
- Metastatic or locally advanced and inoperable tumor
- Clear disease progression on Octreotide within less than 3 years (RECIST 1.1 criteria)
- Disease presence within 24 weeks identified by PET/CT scans with Ga-68 DOTATATE or FDG
- Well differentiated tumor pathology with Ki67 less than 20%
- Octreotide positive on pathology or PET/CT imaging showing Ga-68 DOTATATE uptake
- Laboratory values within required limits: creatinine less than 1.7, hemoglobin greater than 8, white blood cells greater than 2,000, platelets greater than 75,000, bilirubin less than three times normal limit
- No Octreotide treatment within 30 days before administration
- Willing and able to follow protocol requirements
- Able to understand and sign informed consent in English
You will not qualify if you...
- Not meeting all the inclusion criteria listed above for the study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 years from date of procedure
Participants who received treatment of gastroenteropancreatic primary neuroendocrine tumors with peptide receptor radionuclide therapy (PRRT) are observed to collect clinical data related to treatment responses, survival outcomes, adverse events, and complications.
Regular visits as per treating physician's discretion
Trial Site Locations
Total: 2 locations
1
Clinical Research Institute at Methodist Health System
Dallas, Texas, United States, 75203
Actively Recruiting
2
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Enrolling by Invitation
Research Team
C
Colette N Ndjom, MS
J
Jennifer Kirchner
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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