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

NCT04069299 | Completed FDA Drug

• 1 other identifier: MCC-19943
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Uniformly Positive 68Ga-dotatate PET

  Percentage of participants with uniformly positive 68Ga-dotatate PET (positivity defined as SUV uptake \> liver for all tumors at least 1cm in size). Note: Standard Uptake Value (SUV) is used to determine activity in PET imaging.

  Up to 10 months

Secondary Outcomes (1)

• Percentage of Participants with No Uptake to Very High Uptake on PET

  Up to 10 months

Study Arms (1)

Participants receiving PET scan

Participants with metastatic poorly-differentiated neuroendocrine carcinomas of the GI tract

Drug: 68Ga-DOTATATE; Diagnostic Test: Positron Emission Tomography (PET) Scan

Interventions

68Ga-DOTATATE DRUG

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

Also known as: NETspot

Participants receiving PET scan

Positron Emission Tomography (PET) Scan DIAGNOSTIC_TEST

PET scan is an imaging test using radioactive tracers.

Participants receiving PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of Moffitt Cancer Center's GI Clinic

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female ≥ 18 years old
• Histologically confirmed diagnosis of poorly-differentiated neuroendocrine carcinoma of the gastroenteropancreatic tract or unknown primary
• Evidence of measurable disease per RECIST 1.1 on another imagine modality (CT, MRI or FDGPET) with at least 3 tumors \>1cm in largest diameter. CT, MRI or Fluorodeoxyglucose (FDG)-PET must have been performed within 2 months of the study scan. (Of note, participants may sign consent for the study prior to scheduling of said CT, MRI or FDG-PET, but will be considered screen failures if the CT/MRI/FDG-PET does not reveal at least 3 tumors \>1cm).

You may not qualify if:

• Participants with well-differentiated neuroendocrine tumors
• Participants who have undergone 68Ga-dotatate PET scan in the past
• Pregnant women and/or breastfeeding women. Women of child bearing potential must have a negative pregnancy test prior to scan.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Advanced Accelerator Applications: collaborator

Study Sites (1)

H Lee Moffitt Cancer & Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

gallium Ga 68 dotatate; Positron-Emission Tomography; Radionuclide Imaging

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Jonathan Strosberg, MD

  H Lee Moffitt Cancer & Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: September 25, 2019
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)