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68Ga DOTATATE PET/CT in Neuroendocrine Tumors (Expanded Access)

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.
 
ClinicalTrials.gov Identifier: NCT02174679
Expanded Access Status : No longer available
First Posted : June 25, 2014
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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Brief Summary:
To evaluate 68Ga-DOTATATE PET/CT for staging of patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.

Condition or disease Intervention/treatment
Carcinoid Cancer Neuroendocrine Tumors Medullary Thyroid Cancer Cancers Expressing Somatostatin Receptors Drug: 68Ga DOTATATE

Detailed Description:
This is an expanded access study with a total of 300 participants with NET and suspected SSTR positive tumors. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-DOTATATE and will undergo a PET/CT imaging study. All patients referred by Oncologists will be screened by a UCLA Nuclear Medicine physician and then accepted for scanning if clinically appropriate.
Study Design
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Study Type : Expanded Access
Official Title: 68Ga-DOTATATE Imaging in Neuroendocrine Tumors

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: 68Ga DOTATATE
    Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTATATE PET/CT.
    Other Name: 68Ga DOTATATE PET/CT Scan
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Older than 18 years the time of radiotracer administration
  • Provides written informed consent
  • Known diagnosis of NET or suspected SSTR positive tumors Women of childbearing age must have a negative pregnancy test at screening/baseline
  • Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion Criteria:

  • Less than 18 years-old at the time of radiotracer administration
  • Pregnant or nursing
  • 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 concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
Contacts and Locations
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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): NCT02174679


Locations
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United States, California
UCLA Hospital
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Johannes Czernin, MD University of California, Los Angeles
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02174679    
Other Study ID Numbers: DOTATATE12-001920EA
NCI-2016-01796 ( Other Identifier: CTRP )
JCCCID324 ( Other Identifier: Jonsson Comprehensive Cancer Center )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: May 2019
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue