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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
View on ClinicalTrials.gov →
NCT04090034
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 6.3Conditions3
CancerGastroenteropancreatic Neuroendocrine TumorNeuroendocrine Tumors
Locations2 sites
Clinical Research Institute at Methodist Health System
Dallas, Texas, 75203
Methodist Dallas Medical Center
Dallas, Texas, 75203
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
SponsorMethodist Health System
Started2024-03-28
Est. completion2026-06-28
Eligibility
Age18 Years+
Locations2 sites
View on ClinicalTrials.gov →
NCT04090034