68Ga DOTA-TATE PET/CT in Somatostatin Receptor Positive Tumors
Conditions
Carcinoid Tumors - Islet Cell (Pancreatic NET) - Other Neuroendocrine Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Neoplasms - Neuroendocrine Tumors
Study Type
Expanded Access
Study Phase
Phase 2
Study Design
N/A
Intervention
Name: 68Ga-DOTA TATE
Type: Drug
Overall Status
Available
Summary
The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Greater than 18 years-old at the time of radiotracer administration

- Provides written informed consent

- Known diagnosis of NET or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen when clinically indicated

- Karnofsky score greater than 50 or ECOG Performance Status 0-2

- Women of childbearing age must have a negative pregnancy test at screening/baseline

- Able to remain still for duration of each imaging procedure (about one hour)

Exclusion Criteria:

- Less than 18 years-old at the time of radiotracer administration

- Pregnant or nursing

- Serum creatinine >3.0 mg/dL

- Hepatic enzyme levels more than 5 times upper limit of normal.

- 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.

- Inability to lie still for the entire imaging time

- 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.
Location
Stanford University Cancer Institute
Stanford, California, United States
Status:
Start Date
November 2013
Completion Date
November 2019
Sponsors
Andrei Iagaru
Source
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page