Evaluation of Gallium-68 DOTA-TOC Imaging of Somatostatin Receptor Positive Malignancies
Conditions
Neuroendocrine Tumor - Paraganglioma - Carcinoid Tumors - Neuroblastoma
Conditions: official terms
Apudoma - Carcinoid Tumor - Neuroblastoma - Neuroendocrine Tumors - Paraganglioma
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: DOTA-TOC PET/CT
Type: Drug
Overall Status
Recruiting
Summary
The primary objective of this study is to determine if Gallium-68 labeled DOTA-TOC will result in the delineation of more lesions in patients with somatostatin receptor positive malignancies than with conventional imaging.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 > 18.

- Karnofsky performance status of > 50 (or ECOG/WHO equivalent).

- Not pregnant. A negative serum pregnancy test is required for all female subjects with child-bearing 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 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.)

- 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.
Location
UCSF Imaging Center at China Basin
San Francisco, California, United States
Status: Recruiting
Contact: Thomas Hope, MD - thomas.hope@ucsf.edu
Start Date
June 2014
Sponsors
University of California, San Francisco
Source
University of California, San Francisco
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page