Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
300 participants
INTERVENTIONAL
2014-06-23
2017-08-07
Brief Summary
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Detailed Description
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I. To determine if gallium Ga 68-DOTA-TOC (gallium-68 labeled DOTA-TOC) results in the delineation of more lesions than with conventional imaging.
SECONDARY OBJECTIVES:
I. To determine if the incorporation of gallium (Ga)-68 DOTA-TOC PET/CT into the management decision making process results in a change in stage of the patient.
OUTLINE:
Patients receive gallium Ga 68-DOTA-TOC intravenously (IV) over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes.
After completion of study, patients are followed up for 2 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Ga-68 DOTA-TOC PET/CT
Patients receive Gallium Ga 68-DOTA-TOC IV over 1-2 minutes. Within 55-70 minutes, patients then undergo either a PET/CT scan lasting 30-40 minutes or a PET/MRI scan lasting 50 minutes.
Computed Tomography (CT)
Undergo Gallium Ga 68-DOTA-TOC PET/CT
Gallium Ga 68-Edotreotide
Given Intravenously (IV) before imaging
Magnetic Resonance Imaging (MRI)
Undergo gallium Ga 68-DOTA-TOC PET/MRI
Positron Emission Tomography (PET)
Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI
Interventions
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Computed Tomography (CT)
Undergo Gallium Ga 68-DOTA-TOC PET/CT
Gallium Ga 68-Edotreotide
Given Intravenously (IV) before imaging
Magnetic Resonance Imaging (MRI)
Undergo gallium Ga 68-DOTA-TOC PET/MRI
Positron Emission Tomography (PET)
Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 1.
* Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) equivalent).
* Not pregnant. A negative serum pregnancy test is required for all female subjects with childbearing potential.
* Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
* Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET /CT scanner due to BMI
* Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.); although at Mission Bay Hospital pediatric patients may be sedated per clinical protocol.
* 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.
* Recognized concurrent active infection Previous systemic or radiation treatment for another cancer of any type within the last 2 months.
* 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
2 Years
ALL
No
Sponsors
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Peterson Family Foundation
UNKNOWN
University of California, San Francisco
OTHER
Responsible Party
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Thomas Hope
Assistant Professor of Radiology and Biomedical Engineering
Principal Investigators
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Thomas A Hope, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2017-00451
Identifier Type: REGISTRY
Identifier Source: secondary_id
14453-HDFCCC
Identifier Type: -
Identifier Source: org_study_id
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