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

Expanded access is currently available for this treatment.
Verified May 2016 by Stanford University
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University
ClinicalTrials.gov Identifier:
First received: November 4, 2013
Last updated: May 20, 2016
Last verified: May 2016
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 Phase
Carcinoid Tumors
Islet Cell (Pancreatic NET)
Other Neuroendocrine Tumors
Drug: 68Ga-DOTA TATE
Phase 2

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 Stanford University:

Study Start Date: November 2013
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01980732

Contact: Phuong Pham 650-725-9810 ppham5@stanford.edu

United States, California
Stanford University Cancer Institute
Stanford, California, United States, 94305
Principal Investigator: Andrei Iagaru         
Sponsors and Collaborators
Andrei Iagaru
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 
Study First Received: November 4, 2013
Last Updated: May 20, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 26, 2016