NCT02177773

GA-68 DOTA-TOC of Somatostatin Positive Malignancies

Evaluation of Gallium-68 DOTA-TOC Imaging of Somatostatin Receptor Positive Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed pictures of areas where material accumulates in the body. Diagnostic procedures, such as gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor positive tumors and help plan the best treatment.

Detailed description

PRIMARY OBJECTIVES: I. To determine if gallium Ga 68-DOTA-TOC (gallium-68 labeled DOTA-TOC) results in the delineation of more lesions than with conventional imaging. SECONDARY OBJECTIVES: I. To determine if the incorporation of gallium (Ga)-68 DOTA-TOC PET/CT into the management decision making process results in a change in stage of the patient. OUTLINE: Patients receive gallium Ga 68-DOTA-TOC intravenously (IV) over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes. After completion of study, patients are followed up for 2 weeks.

Conditions

• Neuroendocrine Tumor
• Paraganglioma
• Carcinoid Tumors
• Neuroblastoma

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography (CT)	Undergo Gallium Ga 68-DOTA-TOC PET/CT
DRUG	Gallium Ga 68-Edotreotide	Given Intravenously (IV) before imaging
PROCEDURE	Magnetic Resonance Imaging (MRI)	Undergo gallium Ga 68-DOTA-TOC PET/MRI
PROCEDURE	Positron Emission Tomography (PET)	Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI

Timeline

• Start date: 2014-06-23
• Primary completion: 2017-08-07
• Completion: 2017-08-07
• First posted: 2014-06-30
• Last updated: 2019-11-12
• Results posted: 2019-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study