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Gallium-68 DOTATOC for Management of Neuroendocrine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02375464
Expanded Access Status : No longer available
First Posted : March 2, 2015
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Stephen Scharf, Northwell Health

Tracking Information
First Submitted Date February 24, 2015
First Posted Date March 2, 2015
Last Update Posted Date November 8, 2016
 
Descriptive Information
Brief Title Gallium-68 DOTATOC for Management of Neuroendocrine Tumors
Brief 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.

Study Type Expanded Access
Intervention Drug: Gallium-68 DOTATOC
Imaging with Gallium-68 DOTATOC
Other Name: Gallium-68 (DOTA0-Phe1-Tyr3)octreotide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02375464
Responsible Party Stephen Scharf, Northwell Health
Study Sponsor Northwell Health
Collaborators Not Provided
Investigators
Principal Investigator: STEPHEN C SCHARF, MD Lenox Hill Hospital
PRS Account Northwell Health
Verification Date November 2016