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

NCT04090034 | Recruiting

• 1 other identifier: 022.HPB.2019.D
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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

Gastroenteropancreatic Neuroendocrine Tumor; Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (11)

• Demographics and other patient data

  (such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis)

  7 years from date of procedure

• Tumor specific data

  Tumor site, tumor grade, stage, presence of tumor necrosis, number of mitoses and percentage of Ki-67 and MIB-1 positive cells (proliferative index)

  7 years from date of procedure

• Use of somatostatin analogs

  at the time of PRRT, location, isotope used and dose of isotope for each PRRT

  7 years from date of procedure

• Biomarker data (chromogranin A and pancreastatin)

  at the time of diagnosis, before and after the first PRRT, and after the second PRRT were also extracted

  7 years from date of procedure

• Diagnostic imaging findings

  prior to PRRT and response after PRRT, date of progression on imaging after PRRT, and status of disease on imaging at the last follow-up were also recorded

  7 years from date of procedure

• Overall survival (OS)

  the time from diagnosis to death of any cause.

  7 years from date of procedure

• Time to progression (TTP)

  the time from the first PRRT until any progression on diagnostic imaging

  7 years from date of procedure

• Treatment responses and progression

  assessed with cross-sectional imaging with either computerized tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET) or single-photon emission computed tomography (SPECT).

  7 years from date of procedure

• Response

  any response of any magnitude

  7 years from date of procedure

• Disease progression

  any increase in lesion sizes and/or appearance of new metastatic lesions on diagnostic imaging exams.

  7 years from date of procedure

• Adverse events

  will be assessed by the investigator who will determine whether or not the event is related to PRRT or related to progression of disease (gastroenteropancreatic primary NET), and whether or not the event meets serious criteria. AEs related to PRRT will be recorded in the study registry.

  7 years from date of procedure

Study Arms (1)

Treated w PRRT

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

Procedure: Peptide Receptor Radionuclide Therapy

Interventions

Peptide Receptor Radionuclide Therapy PROCEDURE

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

Treated w PRRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be screened for NETs per standard of care. Those patients, who have or will undergo the PRRT procedure, will be offered the opportunity to participate in this registry study.

You 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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (2)

Clinical Research Institute at Methodist Health System

Dallas, Texas, 75203, United States

RECRUITING

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

ENROLLING BY INVITATION

MeSH Terms

Conditions

Neuroendocrine Tumors; Gastro-enteropancreatic neuroendocrine tumor

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Alejandro Mejia, MD

  Liver Institute at Methodist Dallas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colette N Ndjom, MS

CONTACT

214-947-1280; clinicalresearch@mhd.com

Jennifer Kirchner

CONTACT

214-947-1280; clinicalresearch@mhd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: March 28, 2024
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): June 28, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (2)