Adult Glioblastoma Clinical Trial
Official title:
Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors
Verified date | April 2017 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and diagnose brain tumors.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 29 Years |
Eligibility |
Inclusion Criteria: - Patients presenting with brain tumors will be eligible for this study - Eligible subjects must be able and willing to undergo the procedures of the study - Electronic version of pre-surgery MRI must be available for co-registration purposes - Fresh frozen tumor, and/or paraffin block of biopsy or resected tumor is recommended, but not required to determine expression of somatostatin receptors in tumor by immunohistochemistry and/or quantitative polymerase chain reaction (qPCR) Exclusion Criteria: - Women who are pregnant or breastfeeding - Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin of body that would preclude obtaining an MRI as part of the initial study evaluation - Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons - Presence of any additional medical condition such as inter-current illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Sue O'Dorisio | National Cancer Institute (NCI), Ride for Kids |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide | The endpoint is a binary outcome (+ or -) of SUV uptake (after gallium Ga 68-edotreotide) and a binary outcome confirmed at biopsy (+ or -). | Baseline up to 30 days | |
Primary | Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy | Up to 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
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