Gallium-68 DOTATOC for Management of Neuroendocrine Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2015-04-30

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Neuroendocrine Tumors

Keywords

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neuroendocrine tumor carcinoid tumor

Interventions

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Gallium-68 DOTATOC

Imaging with Gallium-68 DOTATOC

Intervention Type DRUG

Other Intervention Names

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Gallium-68 (DOTA0-Phe1-Tyr3)octreotide

Eligibility Criteria

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Inclusion Criteria

* Proven or suspected neuroendocrine tumor Physician referral for imaging

Exclusion Criteria

* Pregnancy

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Stephen Scharf

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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STEPHEN C SCHARF, MD

Role: PRINCIPAL_INVESTIGATOR

Lenox Hill Hospital

Other Identifiers

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15-0587

Identifier Type: -

Identifier Source: org_study_id