RECRUITING

Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine

Quick Facts

Study Start:2024-03-28
Study Completion:2024-06-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04090034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. \> 18 years of age
  2. 2. Diagnosed with gastroenteropancreatic primary NET and has consented to undergo PRRT per the treating physician. Specifically:
  3. * Will consider other primaries on a case by case basis if dotatate scan (+) and meet all other criteria.
  4. * Metastatic or Locally Advanced AND Inoperable
  5. * Clear disease progression on Octreotide over less than 3 years (RECIST 1.1)
  6. * 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
  7. * Well differentiated on path - Ki67 \< 20%
  8. * Octreotide positive on pathology (if not documented, acceptable if PET/CT imaging shows lesions with Ga-68 DOTATATE uptakeLabs:
  9. * Cr. \<1.7
  10. * Hgb \>8
  11. * WBC \>2K
  12. * Plt \>75K
  13. * Bili \< 3x normal limit
  14. * No Octreotide within 30 days of administration.
  15. 3. Willing and able to comply with the protocol requirements
  16. 4. Able to comprehend and sign the Informed Consent Form in English.
  1. * Do not meet the Study Inclusion Criteria laid out in section 6.3

Contacts and Locations

Study Contact

Colette N Ndjom, MS
CONTACT
214-947-1280
MHSIRB@mhd.com
Loretta W Bedell, MPH
CONTACT
214-947-4680
mhsirb@mhd.com

Principal Investigator

Alejandro Mejia, MD
PRINCIPAL_INVESTIGATOR
Liver Institute at Methodist Dallas Medical Center

Study Locations (Sites)

Clinical Research Institute at Methodist Health System
Dallas, Texas, 75203
United States
Methodist Dallas Medical Center
Dallas, Texas, 75203
United States

Collaborators and Investigators

Sponsor: Methodist Health System

  • Alejandro Mejia, MD, PRINCIPAL_INVESTIGATOR, Liver Institute at Methodist Dallas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-28
Study Completion Date2024-06-28

Study Record Updates

Study Start Date2024-03-28
Study Completion Date2024-06-28

Terms related to this study

Additional Relevant MeSH Terms

  • Neuroendocrine Tumors