GA-68 DOTA-TOC of Somatostatin Positive Malignancies

• Status: Terminated
• Trial end date: 2017-08-07
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed pictures of areas where material accumulates in the body. Diagnostic procedures, such as gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor positive tumors and help plan the best treatment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Peterson Family Foundation
• Treatments: Edotreotide; Octreotide; Somatostatin

Criteria

Inclusion Criteria:

• Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.

• Age > 1.

• Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) equivalent).

• Not pregnant. A negative serum pregnancy test is required for all female subjects with childbearing potential.

• Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

• Hepatic enzymes 5 times greater than the upper limits of normal, serum creatinine > 3.0 mg/dL (270 Micromole per liter (uM/L).

• Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET /CT scanner due to BMI

• Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.); although at Mission Bay Hospital pediatric patients may be sedated per clinical protocol.

• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).

• Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

• Recognized concurrent active infection Previous systemic or radiation treatment for another cancer of any type within the last 2 months.

• Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments