A Phase 2 interventional study of Gallium citrate in Lymphoma, Large B-Cell, Diffuse and Burkitt Lymphoma, sponsored by University of California, San Francisco. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-10.
Sponsored by University of California, San Francisco · Phase 2, Interventional, and Diagnostic
This is a single center imaging study investigating the use of PET with 68Ga-citrate in patients with DLBCL or BCLU.
This is a single center feasibility imaging study in patients with diffuse large B-cell lymphoma (DLBCL) or B-cell Lymphoma, Unclassifiable with features between DLBCL and Burkitt's (BCLU). Study participants will undergo PET/MRI of the whole body with 68Ga citrate.
The study will include at least 5 patients with double hit lymphoma and 5 patients with DLBCL with an additional 5 more patients as expansion once the dose level has been established. Patients with DLBCL will be included once an optimal dose level for the resolution of cancer lesions has been established.
391 studies on the registry are indexed under Burkitt Lymphoma; 113 are open to participants now.
Browse Burkitt Lymphoma studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Histologically confirmed DLBCL or BCLU.
Exclusion Criteria:
The patients will be organized into two cohorts. Cohort 1 will receive 10 mCi and will be imaged 4 and 6 hours post injection. Cohort 2 will receive 15 millicurie (mCi) and will be imaged 4 and 6 hours post injection. Cohort 2 will be imaged if the optimal protocol identified image quality from cohort 1 does not allow for the resolution of cancer lesions.
Drug: Gallium citrate
Ga-68 citrate will be administered on an outpatient basis at the Center for Molecular and Functional Imaging at China Basin. It will be administered a single time point intravenously prior to PET imaging. The one-time nominal injected dose will be up to 15 mCi containing 10 - 25 μg Ga-68. A simultaneous MRI (PET/MRI) of the head will be used for attenuation correction and anatomic localization of gallium-68 citrate uptake and standardized uptake value (SUV) calculation.
Also known as: Ga-68 citrate
Uptake of radiotracer in tumor tissue
To show evidence of specific uptake of the radiotracer in the tumor tissue compared to background. For exploratory radiotracer studies, this is typically defined as 1.5-2 fold increase in SUVmax in the tumor compared to mediastinal blood pool activity.
Time frame: 16 months
Comparing Gallium citrate uptake
To compare 68Ga-citrate (standard uptake value, metabolic tumor volume) between patients with Double Hit Lymphoma (DHL) and with diffuse B-cell lymphoma without aberrant MYC expression
Time frame: 16 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco