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68Ga DOTA-TATE PET/CT in Somatostatin Receptor Positive Tumors

Sponsor
Andrei Iagaru (Other)
Overall Status
No longer available
CT.gov ID
NCT01980732
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.

Condition or Disease Intervention/Treatment Phase
  • Drug: 68Ga-DOTA TATE

Study Design

Study Type:
Expanded Access
Official Title:
68Ga DOTA-TATE PET/CT in the Evaluation of Patients With Somatostatin Receptor Positive Tumors

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Greater than 18 years-old at the time of radiotracer administration

    • Provides written informed consent

    • Known diagnosis of NET or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen when clinically indicated

    • Karnofsky score greater than 50 or ECOG Performance Status 0-2

    • Women of childbearing age must have a negative pregnancy test at screening/baseline

    • Able to remain still for duration of each imaging procedure (about one hour)

    Exclusion Criteria:

    • Less than 18 years-old at the time of radiotracer administration

    • Pregnant or nursing

    • Serum creatinine >3.0 mg/dL

    • Hepatic enzyme levels more than 5 times upper limit of normal.

    • Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.

    • Inability to lie still for the entire imaging time

    • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

    • Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University, School of Medicine Stanford California United States 94305

    Sponsors and Collaborators

    • Andrei Iagaru

    Investigators

    • Principal Investigator: Andrei Iagaru, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrei Iagaru, Assistant Professor of Radiology - Nuclear Medicine, Stanford University
    ClinicalTrials.gov Identifier:
    NCT01980732
    Other Study ID Numbers:
    • NET0017
    • 26988
    First Posted:
    Nov 11, 2013
    Last Update Posted:
    Aug 23, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:
    Neoplasms
    Neuroendocrine Tumors
    Carcinoid Tumor

    Study Results

    No Results Posted as of Aug 23, 2017