Status:
UNKNOWN
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
Lead Sponsor:
Methodist Health System
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Brief 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 gas...
Detailed Description
Neuroendocrine tumors (NETs) make up a large range of malignancies that arise from neuroendocrine cells in multiple organs of the body. Hallet et al conducted a large population-based study that demon...
Eligibility Criteria
Inclusion
- \> 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.
Exclusion
- Do not meet the Study Inclusion Criteria laid out in section 6.3
Key Trial Info
Start Date :
March 28 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 28 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04090034
Start Date
March 28 2024
End Date
June 28 2024
Last Update
March 27 2024
Active Locations (2)
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1
Clinical Research Institute at Methodist Health System
Dallas, Texas, United States, 75203
2
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203