NCT03136328

Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga) -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT). Participants with histologically and/or clinically confirmed and/or suspected NET will be enrolled.

Detailed description

This is a prospective, Phase 2, single center study of participants with Neuroendocrine Tumors (NETs). Study participants will receive 68Ga-DOTATOC. DOTATOC is a somatostatin analogue that localizes on the somatostatin receptors expressed by NETs and is attached to a radioactive material called Gallium 68. Participants will undergo a PET/CT imaging study to investigate 68Ga-DOTATOC's suitability as a positron emission tomography (PET) imaging agent for NETs. The radiation (imaging) dose will be 111-185 megabecquerel (MBq) (3 - 5 mCi) ± 25%. All doses after labeling will be presented in buffered solution for intravenous injection. Imaging will start 90 ±30 minutes after injection. Sensitivity and specificity of this imaging technique will be compared with those of conventional imaging modality including CT, MRI and In-111 Octreoscan performed within 6-12 months before or after PET/CT.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	68Ga-DOTATOC	The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.

Timeline

• Start date: 2016-05-16
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2017-05-02
• Last updated: 2023-05-09
• Results posted: 2019-01-30

Regulatory

• FDA-regulated drug study