68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)

• Conditions: Carcinoid Cancer; Neuroendocrine Tumors; Cancers Expressing Somatostatin Receptors; Medullary Thyroid Cancer

• Registration Number: NCT02174679
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief Summary

To evaluate 68Ga-DOTATATE PET/CT for staging of patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.

Detailed Description

This is an expanded access study with a total of 300 participants with NET and suspected SSTR positive tumors. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-DOTATATE and will undergo a PET/CT imaging study. All patients referred by Oncologists will be screened by a UCLA Nuclear Medicine physician and then accepted for scanning if clinically appropriate.

Study Timeline

• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Status Verified: 2019-05
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

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

Inclusion Criteria

• Older than 18 years the time of radiotracer administration
• Provides written informed consent
• Known diagnosis of NET or suspected SSTR positive tumors Women of childbearing age must have a negative pregnancy test at screening/baseline
• Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion Criteria

• Less than 18 years-old at the time of radiotracer administration
• Pregnant or nursing
• 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 concurrent 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)

UCLA Hospital; 🇺🇸 Los Angeles, California, United States