Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
Recruiting now
Conditions studied: Neuroendocrine Tumors, Gastroenteropancreatic Neuroendocrine Tumor
In brief
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.
Key facts
- Study ID
- NCT04090034
- Run by
- Methodist Health System
- People needed
- 50
- Starts
- 2024-03-28
- Expected to finish
- 2026-06-28
- Last updated by the study team
- 2026-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- > 18 years of age
- 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.
- Willing and able to comply with the protocol requirements
- Able to comprehend and sign the Informed Consent Form in English.
You may not qualify if…
- Do not meet the Study Inclusion Criteria laid out in section 6.3
Where it is running
- Clinical Research Institute at Methodist Health System — Dallas, Texas, United States (enrolling)
- Methodist Dallas Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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