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

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ClinicalTrials.gov Identifier: NCT02174679
Expanded Access Status : No longer available
First Posted : June 25, 2014
Last Update Posted : June 4, 2019
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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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:
UCLA Ahmanson Translational Imaging Division  This link exits the ClinicalTrials.gov site

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     History of Changes
Other Study ID Numbers: DOTATATE12-001920EA
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Thyroid Neoplasms
Neuroendocrine Tumors
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
 Endocrine System Diseases
Thyroid Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue