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Gallium-68 DOTATOC for Management of Neuroendocrine Tumors

Primary Purpose

Neuroendocrine Tumors

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Gallium-68 DOTATOC
Sponsored by
Northwell Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Neuroendocrine Tumors focused on measuring neuroendocrine tumor, carcinoid tumor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Proven or suspected neuroendocrine tumor Physician referral for imaging

Exclusion Criteria:

  • Pregnancy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2015
    Last Updated
    November 4, 2016
    Sponsor
    Northwell Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02375464
    Brief Title
    Gallium-68 DOTATOC for Management of Neuroendocrine Tumors
    Official Title
    Gallium-68 DOTATOC for Management of Neuroendocrine Tumors
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    No longer available
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwell Health

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuroendocrine Tumors
    Keywords
    neuroendocrine tumor, carcinoid tumor

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Gallium-68 DOTATOC
    Other Intervention Name(s)
    Gallium-68 (DOTA0-Phe1-Tyr3)octreotide
    Intervention Description
    Imaging with Gallium-68 DOTATOC

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Proven or suspected neuroendocrine tumor Physician referral for imaging Exclusion Criteria: Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    STEPHEN C SCHARF, MD
    Organizational Affiliation
    Lenox Hill Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Gallium-68 DOTATOC for Management of Neuroendocrine Tumors

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