NCT03001349

68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors

An Expanded Access Imaging of Neuroendocrine Tumors Using 68Ga-DOTA-TOC

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This trial studies how well gallium Ga 68-edotreotide (68Ga-DOTA-TOC) positron emission tomography (PET)/computer tomography (CT) works in imaging participants with neuroendocrine tumors. 68Ga-DOTA-TOC is used as a tracer chemical during PET/CT scans. Diagnostic procedures, such as 68Ga-DOTA-TOC PET/CT, may help find and diagnose neuroendocrine tumors.

Detailed description

PRIMARY OBJECTIVES: I. To substitute 68Ga-DOTATOC for 111In-pentetreotide on an expanded access basis, in tumor imaging for study subjects, where the care provider believes that somatostatin imaging is clinically indicated, until such time as 68Ga-DOTATOC becomes commercially available. SECONDARY OBJECTIVES: I. To gain experience in the utility of 68Ga-DOTATOC in the management of neuroendocrine tumors at The University of Texas M.D. Anderson Cancer Center (MDACC). II. To acquire proficiency in generating 68Ga-DOTATOC for human use at MDACC. OUTLINE: Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants undergo PET/CT scan over 60 minutes. After completion of study, participants are followed up at 24 hours or within 72 hours, and at 30 days.

Conditions

• Meningioma
• Metastatic Well Differentiated Neuroendocrine Neoplasm
• Multiple Endocrine Neoplasia Type 1
• Neuroendocrine Neoplasm
• Somatostatin Positive Neoplastic Cells Present
• Von Hippel-Lindau Syndrome

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT
DRUG	Gallium Ga 68-Edotreotide	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2017-05-16
• Primary completion: 2021-02-05
• Completion: 2021-02-05
• First posted: 2016-12-23
• Last updated: 2021-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study