NCT02375464

Gallium-68 DOTATOC for Management of Neuroendocrine Tumors

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Gallium-68 DOTATOC is a material used to find neuroendocrine tumors (NETs) using positron emission tomography (PET scan). The material has already been shown to be better than the currently available imaging agents. This study is designed to evaluate the clinical impact of PET CT scanning using this agent in the evaluation and management of patients with NETs.

Detailed description

Patients with NETs will be evaluated by their own physicians. Before doing the PET scan using Gallium-68 DOTATOC, the physicians will be asked to describe the type of treatment that they would recommend. After the test is performed and the result reviewed, the physician will be asked to reevaluate the therapeutic and management options. Data will be analyzed to determine the impact of the testing on patient management. Gallium-68 has been designated an "orphan drug" due to the relative rarity of NETs. It is expected that the data collected from this and other similar trials will be used to provide data to the FDA regarding the safety and efficacy of this drug as an imaging agent for NETs and ultimately lead to FDA approval.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Gallium-68 DOTATOC	Imaging with Gallium-68 DOTATOC

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2015-03-02
• Last updated: 2016-11-08