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

NCT ID: NCT01980732

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Carcinoid Tumors; Islet Cell (Pancreatic NET); Other Neuroendocrine Tumors

Interventions

68Ga-DOTA TATE

Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTA TATE PET/CT in addition to conventional imaging.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andrei Iagaru

OTHER

Sponsor Role: lead

Responsible Party

Andrei Iagaru

Assistant Professor of Radiology - Nuclear Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrei Iagaru

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University, School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

26988

Identifier Type: -

Identifier Source: secondary_id

NET0017

Identifier Type: -

Identifier Source: org_study_id