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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04090034
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Methodist Health System
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alejandro Mejia, MD
Principal Investigator Affiliation Liver Institute at Methodist Dallas Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Neuroendocrine Tumors
Additional Details

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.

Arms & Interventions

Arms

: Treated w PRRT

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dallas, Texas

Status

Recruiting

Address

Clinical Research Institute at Methodist Health System

Dallas, Texas, 75203

Site Contact

Colette N Ndjom, MS

ColetteNgoNdjom@mhd.com

410-947-4681 #74681

Methodist Dallas Medical Center, Dallas, Texas

Status

Enrolling by invitation

Address

Methodist Dallas Medical Center

Dallas, Texas, 75203

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