RecruitingNCT04090034
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine
Sponsor
Methodist Health System
Enrollment
50 participants
Start Date
Mar 28, 2024
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria16
- \> 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.
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Interventions
PROCEDUREPeptide Receptor Radionuclide Therapy
a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT04090034
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