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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. Identifier: NCT02375464
Expanded Access Status : No longer available
First Posted : March 2, 2015
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
Stephen Scharf, Northwell Health

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.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Drug: Gallium-68 DOTATOC

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.

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Study Type : Expanded Access
Official Title: Gallium-68 DOTATOC for Management of Neuroendocrine Tumors
Study Start Date : April 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Intervention Details:
  • Drug: Gallium-68 DOTATOC
    Imaging with Gallium-68 DOTATOC
    Other Name: Gallium-68 (DOTA0-Phe1-Tyr3)octreotide

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Proven or suspected neuroendocrine tumor Physician referral for imaging

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02375464

Sponsors and Collaborators
Northwell Health
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Principal Investigator: STEPHEN C SCHARF, MD Lenox Hill Hospital
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Responsible Party: Stephen Scharf, Principal Investigator, Northwell Health Identifier: NCT02375464    
Other Study ID Numbers: 15-0587
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Keywords provided by Stephen Scharf, Northwell Health:
neuroendocrine tumor
carcinoid tumor
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents