Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers

NCT03623984 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: IRB-300001980
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Neuroendocrine Carcinoma of Pancreas; Carcinoid

Keywords

Gallium-DOTATATE (68); Neuroendocrine Tumors; Pancreatic neuroendocrine Tumors; Molecular; Surgery; Carcinoid

Outcome Measures

Primary Outcomes (1)

• Comparison of intraoperative findings to preoperative PET scan findings

  PET probes will be used to quantify the level of gallium dotatate in the tumor tissue and be compared to the gallium dotatate uptake of the preoperative PET scan.

  From initial PET scan (2-3 weeks) until completion of the surgery

Secondary Outcomes (1)

• Determine threshold levels of gallium dotatate uptake in order to determine tumor involvement

  From baseline through 12 months

Study Arms (1)

Gallium Dotatate

EXPERIMENTAL

All patients in the study will be undergoing both a 68Gallium-DOTATATE scan for tumor localization and planned surgical resection. Both of these maneuvers are clinically indicated and the standard of care in the care of these patients. Following induction of general endotracheal anesthesia (as required for the surgery portion of treatment), the patients will receive an additional injection of 68Gallium-DOTATATE in the operating room itself. A probe that can detect 68Gallium will be used to identify tumors in the OR within the patient's abdominal cavity for targeted resection.

Drug: Gallium Dotatate

Interventions

Gallium Dotatate DRUG

Radioguided Surgery for Pancreatic- Neuroendocrine Cancers

Also known as: Gallium-DOTATATE (68)

Gallium Dotatate

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 19 years of age and older
• Male or female patient with a suspected diagnosis of a gastrointestinal-pancreatic neuroendocrine tumor (localized or metastatic) to undergo surgery for resection
• Localization of the tumor with a pre-operative 68Gallium-DOTATATE scan
• In the Investigator's judgement, participant is mentally competent to provide informed consent to participate in the study.
• ECOG performance status of 0-1
• Negative urine pregnancy test at screening, if applicable.

You may not qualify if:

• Participants who are pregnant, lactating, or intending to become pregnant during the study
• Female participants of child-bearing age who refuse a urine pregnancy test
• Participants who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
• Participants who have participated in an investigational surgical, drug, or device study within the past 30 days.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Patients whose tumors do not localize on a 68Gallium-DOTATATE scan

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Carcinoid Tumor; Neuroendocrine Tumors

Interventions

gallium Ga 68 dotatate

Condition Hierarchy (Ancestors)

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

Study Officials

• Sushanth Reddy, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 9, 2018
• Study Start: June 7, 2019
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

US (1)