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Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors

RECRUITINGSponsored by Methodist Health System
Actively Recruiting
SponsorMethodist Health System
Started2024-03-28
Est. completion2026-06-28
Eligibility
Age18 Years+
Locations2 sites

Summary

The specific aim is of this study is to gain a better understanding of the patient characteristics, treatment responses, survival outcomes, and adverse events associated with PRRT in patients with gastroenteropancreatic primary NETs.

Eligibility

Age: 18 Years+
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

Conditions3

CancerGastroenteropancreatic Neuroendocrine TumorNeuroendocrine Tumors

Locations2 sites

Clinical Research Institute at Methodist Health System
Dallas, Texas, 75203
Colette N Ndjom, MS410-947-4681ColetteNgoNdjom@mhd.com
Methodist Dallas Medical Center
Dallas, Texas, 75203

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