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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuroendocrine Tumors; Gastroenteropancreatic Neuroendocrine Tumor
• Intervention / Treatment: Procedure: Peptide Receptor Radionuclide Therapy

Detailed Description

Neuroendocrine tumors (NETs) make up a large range of malignancies that arise from neuroendocrine cells in multiple organs of the body. Hallet et al conducted a large population-based study that demonstrated that 21% of NET patients presented with metastatic disease and another 38% developed metastases after resection of the primary tumor (Hallet et al., 2015). This burden demonstrates the need for effective systemic therapy for advanced NETs. Options for systemic therapy include peptide receptor radionuclide therapy (PRRT).

A need for more prospective series are needed on treatment responses and survival outcomes related to gastroenteropancreatic primary NETs treated with PRRT was identified. Thus the purpose of this study is to collect clinical data related to treatment of gastroenteropancreatic primary NETs s with PRRT. Clinical data related to patient characteristics, treatment responses and survival outcomes related to the treatment of gastroenteropancreatic primary NETs with PRRT and on adverse events and complications related to PRRT treatment will be collected.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Colette N Ndjom, MS; Phone Number: 214-947-1280; Email: clinicalresearch@mhd.com
• Study Contact Backup: Name: Jennifer Kirchner; Phone Number: 74459 214-947-1280; Email: clinicalresearch@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Clinical Research Institute at Methodist Health System
      • Principal Investigator: Alejandro Mejia, MD
      • Contact: Colette N Ndjom, MS; Phone Number: 74681 410-947-4681; Email: ColetteNgoNdjom@mhd.com
      • Contact: Loretta W Bedell, MPH; Phone Number: 74680 214-947-4680; Email: lorettabedell@mhd.com
    • Dallas, Texas, United States, 75203
      • Enrolling by invitation
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated w PRRT; Patients who received treatment of gastroenteropancreatic primary NETs with PRRT per the treating physicians discretion.	Procedure: Peptide Receptor Radionuclide Therapy; a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Alejandro Mejia, MD, Liver Institute at Methodist Dallas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): June 28, 2026

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Gastro-enteropancreatic neuroendocrine tumor
• Other Study ID Numbers: 022.HPB.2019.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No