68Ga DOTA-TATE PET/CT in Somatostatin Receptor Positive Tumors

• Conditions: Other Neuroendocrine Tumors; Carcinoid Tumors; Islet Cell (Pancreatic NET)

• Registration Number: NCT01980732
• Lead Sponsor: Andrei Iagaru

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-04
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Stanford, California, United States