Overview

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 NETSPOTĀ® (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