GA-68 DOTA-TOC of Somatostatin Positive Malignancies

Stopped early · Phase 1/Phase 2

Conditions studied: Neuroendocrine Tumor, Paraganglioma, Carcinoid Tumors, Neuroblastoma

In brief

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.

Key facts

Study ID

NCT02177773

Run by

University of California, San Francisco

People needed

300

Starts

2014-06-23

Expected to finish

2017-08-07

Last updated by the study team

2019-11-12

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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