Recruiting

PRRT

Sponsor:

Methodist Health System

Code:

NCT04090034

Conditions

Neuroendocrine Tumors

Gastroenteropancreatic Neuroendocrine Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Peptide Receptor Radionuclide Therapy

Study Details

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 gastroenteropancreatic primary NETs.

Conditions

Neuroendocrine Tumors

Gastroenteropancreatic Neuroendocrine Tumor

Study ID

NCT04090034

Start date

Mar 28, 2024

Status verified date

Mar, 2026

Completion date

Jun 28, 2026

Anticipated

Primary completion date

Jun 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 6.3

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Treated w PRRT

Patients who received treatment of gastroenteropancreatic primary NETs with PRRT per the treating physicians discretion.

Interventions

Peptide Receptor Radionuclide Therapy

a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs

Primary outcome measure

  • Demographics and other patient data [ Time Frame: 7 years from date of procedure ]
  • Tumor specific data [ Time Frame: 7 years from date of procedure ]
  • Use of somatostatin analogs [ Time Frame: 7 years from date of procedure ]
  • Biomarker data (chromogranin A and pancreastatin) [ Time Frame: 7 years from date of procedure ]
  • Diagnostic imaging findings [ Time Frame: 7 years from date of procedure ]
  • Overall survival (OS) [ Time Frame: 7 years from date of procedure ]
  • Time to progression (TTP) [ Time Frame: 7 years from date of procedure ]
  • Treatment responses and progression [ Time Frame: 7 years from date of procedure ]
  • Response [ Time Frame: 7 years from date of procedure ]
  • Disease progression [ Time Frame: 7 years from date of procedure ]
  • Adverse events [ Time Frame: 7 years from date of procedure ]

Central Contacts and Locations

Central contacts

Colette N Ndjom, MS

214-947-1280clinicalresearch@mhd.com

Jennifer Kirchner

214-947-1280clinicalresearch@mhd.com

Locations

Clinical Research Institute at Methodist Health System

Recruiting

Dallas, Texas, United States, 75203

Contacts

Colette N Ndjom, MS

410-947-4681ColetteNgoNdjom@mhd.com

Loretta W Bedell, MPH

214-947-4680lorettabedell@mhd.com

Principal Investigator:

Alejandro Mejia, MD

More Information

Sponsor

Methodist Health System

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Methodist Health System on 2026-03-20.