What this study is
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.
What's being tested
- Peptide Receptor Radionuclide Therapy
Intervention · PROCEDURE
a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs
Study details
- Official title
- Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine
- Sponsor
- Methodist Health System
- Conditions
- Neuroendocrine Tumors · Gastroenteropancreatic Neuroendocrine Tumor
- Enrolling
- 50 people
- Starts
- 2024-03-28
- Est. completion
- 2026-06-28
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join if
- Do not meet the Study Inclusion Criteria laid out in section 6.3
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openClinical Research Institute at Methodist Health System
Dallas, Texas, United States
- Colette N Ndjom, MS · Contact410-947-4681 ext. 74681ColetteNgoNdjom@mhd.com
- Loretta W Bedell, MPH · Contact214-947-4680 ext. 74680lorettabedell@mhd.com
- Alejandro Mejia, MD · Principal investigator
RecruitingMethodist Dallas Medical Center
Dallas, Texas, United States
Enrolling by invitation
Study team
Sponsor
Methodist Health System
Study ID 022.HPB.2019.D
Principal investigator
Alejandro Mejia, MD
Liver Institute at Methodist Dallas Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.