Peptide receptor radionuclide therapy for gastroenteropancreatic neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.