Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers

• Status: Recruiting
• Trial end date: 2023-06-07
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if the use of 68Gallium- positron emission tomography and computer tomography (PET/CT) scans along with NETSPOT® (Advanced Accelerator Applications USA, Inc.) can better define the localization of Neuroendocrine tumors enhancing the surgical removal of Neuroendocrine tumors (NETs).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham

Criteria

Inclusion Criteria:

1. At least 19 years of age and older

2. Male or female patient with a suspected diagnosis of a gastrointestinal-pancreatic neuroendocrine tumor (localized or metastatic) to undergo surgery for resection

3. Localization of the tumor with a pre-operative 68Gallium-DOTATATE scan

4. In the Investigator's judgement, participant is mentally competent to provide informed consent to participate in the study.

5. ECOG performance status of 0-1

6. Negative urine pregnancy test at screening, if applicable.

Exclusion Criteria:

1. Participants who are pregnant, lactating, or intending to become pregnant during the study

2. Female participants of child-bearing age who refuse a urine pregnancy test

3. Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.

4. Participants who have participated in an investigational surgical, drug, or device study within the past 30 days.

5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

6. Patients whose tumors do not localize on a 68Gallium-DOTATATE scan