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

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01980732
First Posted: November 11, 2013
Last Update Posted: August 23, 2017
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.
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University
  Purpose
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 Intervention
Carcinoid Tumors Islet Cell (Pancreatic NET) Other Neuroendocrine Tumors Drug: 68Ga-DOTA TATE

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

Resource links provided by NLM:


Further study details as provided by Andrei Iagaru, Stanford University:

Intervention Details:
    Drug: 68Ga-DOTA TATE
    Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTA TATE PET/CT in addition to conventional imaging.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01980732


Locations
United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Andrei Iagaru
Investigators
Principal Investigator: Andrei Iagaru Stanford University
  More Information

Responsible Party: Andrei Iagaru, Assistant Professor of Radiology - Nuclear Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01980732     History of Changes
Other Study ID Numbers: NET0017
26988
First Submitted: November 4, 2013
First Posted: November 11, 2013
Last Update Posted: August 23, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Neoplasms
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs