Molecular-Guided Surgery for Pancreatic and GI Neuroendocrine Cancers

Phase < 1

Waitlist Available

Led By Sushanth Reddy, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline through 12 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial uses a special scan to help doctors see and remove hard-to-find Neuroendocrine tumors more effectively. The scan uses a tracer that lights up the tumors, making them easier to locate during surgery. This approach aims to improve outcomes for patients with these types of tumors.

Eligible Conditions

Pancreatic Neuroendocrine Tumors
Carcinoid Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline through 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline through 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of intraoperative findings to preoperative PET scan findings

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gallium DotatateExperimental Treatment1 Intervention

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.

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