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Use of 68Ga-dotatate PET Scan in Neuroendocrine Carcinoma of the GI Tract

NCT04069299 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-03-31

No results posted yet for this study

Summary

The purpose of the study is to understand the extent and degree of somatostatin receptor expression in poorly differentiated neuroendocrine carcinomas . This may help to make a determination if a radiolabeled somatostatin analog therapy, also referred to as peptide receptor radiotherapy (PRRT), can be a potential alternative in the future. At this time, radiolabeled somatostatin analogs have not been tested in patients with poorly differentiated neuroendocrine carcinomas, and their efficacy in this disease is not well known Understanding the extent and degree of somatostatin receptor expression is important in order to evaluate the potential of radiolabeled somatostatin analog therapy for treatment of poorly differentiated neuroendocrine carcinomas.

Conditions

  • Neuroendocrine Carcinoma

Interventions

DRUG

68Ga-DOTATATE

The NETspot kit is 2 vials, Vial 1 contains 40 mcg dotatate, 5 mcg 1,10phenanthroline; 6mcg gentisic acid and 20 mg mannitol. Vial 2 contains 60 mg formic acid, 56.5 mg sodium hydroxide and water for injection

DIAGNOSTIC_TEST

Positron Emission Tomography (PET) Scan

PET scan is an imaging test using radioactive tracers.

Sponsors & Collaborators

  • Advanced Accelerator Applications

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jonathan Strosberg, MD · H Lee Moffitt Cancer & Research Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2025-06-02
Completion
2025-06-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04069299 on ClinicalTrials.gov