TheranosticTrials.org

Clinical Trial · NCT02177773

GA-68 DOTA-TOC of Somatostatin Positive Malignancies

Overview

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.

Sponsor

University of California, San Francisco

Phase

Phase 1/2

Contacts

Thomas A Hope, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02177773

Drug / Compound

DOTATOC

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) equivalent).
  • * 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.
  • Ability to understand a written informed consent document, and the willingness to sign it.
  • Not pregnant. A negative serum pregnancy test is required for all female subjects with childbearing potential.
  • Age \> 1.

Exclusion

  • Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
  • Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET /CT scanner due to BMI
  • * Hepatic enzymes 5 times greater than the upper limits of normal, serum creatinine \> 3.0 mg/dL (270 Micromole per liter (uM/L).
  • 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.