Peptide receptor radionuclide therapy for gastroenteropancreatic neuroendocrine tumors
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine
This study will collect information to see how well peptide receptor radionuclide therapy (PRRT) works and how safe it is for adults with gastroenteropancreatic neuroendocrine tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Methodist Health System Academic / other |
| Locations | 2 sites (Dallas, Texas and 1 other locations) |
| Trial ID | NCT04090034 on ClinicalTrials.gov |
What this trial studies
This observational study will prospectively collect clinical data from adults with gastroenteropancreatic neuroendocrine tumors who are treated with PRRT at Methodist Health System. Investigators will record patient characteristics, imaging findings (including Ga-68 DOTATATE and FDG PET/CT with Krenning scores), laboratory values, treatment responses using RECIST 1.1, survival outcomes, and adverse events. Eligible patients are typically somatostatin-receptor–positive, well-differentiated tumors with Ki-67 <20% and documented progression on somatostatin analogues, and they will be followed for response and toxicity after PRRT. The study aggregates real-world outcomes without randomization to better define patterns of benefit and complications.
Who should consider this trial
Good fit: Adults (≥18 years) with gastroenteropancreatic primary NETs that are inoperable or metastatic, somatostatin-receptor–positive on Ga-68 DOTATATE, well differentiated (Ki-67 <20%), with documented progression on octreotide and adequate organ function are ideal candidates.
Not a fit: Patients with poorly differentiated or high‑grade tumors (Ki‑67 ≥20%), lack of somatostatin receptor uptake, significant organ dysfunction, or who do not receive PRRT are unlikely to benefit from the data produced by this observational cohort.
Why it matters
Potential benefit: If successful, the data could help doctors identify which patients benefit most from PRRT and improve treatment planning and follow-up.
How similar studies have performed: Randomized and large-scale studies (for example NETTER‑1) and multiple retrospective series have demonstrated clinical benefit of PRRT in somatostatin-receptor–positive NETs, though prospective series focusing on gastroenteropancreatic primaries remain relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. \> 18 years of age
2. Diagnosed with gastroenteropancreatic primary NET and has consented to undergo PRRT per the treating physician. Specifically:
* Will consider other primaries on a case by case basis if dotatate scan (+) and meet all other criteria.
* Metastatic or Locally Advanced AND Inoperable
* Clear disease progression on Octreotide over less than 3 years (RECIST 1.1)
* Presence of disease within 24 weeks as identified by PET/CT scans with Ga-68 DOTATATE reporting the Krenning score for low-grade NET and/or PET/CT scans with FDG for transformation to high-grade NET
* Well differentiated on path - Ki67 \< 20%
* Octreotide positive on pathology (if not documented, acceptable if PET/CT imaging shows lesions with Ga-68 DOTATATE uptakeLabs:
* Cr. \<1.7
* Hgb \>8
* WBC \>2K
* Plt \>75K
* Bili \< 3x normal limit
* No Octreotide within 30 days of administration.
3. Willing and able to comply with the protocol requirements
4. Able to comprehend and sign the Informed Consent Form in English.
Exclusion Criteria:
* Do not meet the Study Inclusion Criteria laid out in section 6.3
Where this trial is running
Dallas, Texas and 1 other locations
- Clinical Research Institute at Methodist Health System — Dallas, Texas, United States (Recruiting)
- Methodist Dallas Medical Center — Dallas, Texas, United States (Enrolling_by_invitation)
Study contacts
- Principal investigator: Alejandro Mejia, MD — Liver Institute at Methodist Dallas Medical Center
- Study coordinator: Colette N Ndjom, MS
- Email: clinicalresearch@mhd.com
- Phone: 214-947-1280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.