Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse
Conditions
Keywords
lymphoma, gallium citrate, PET
Brief summary
This is a single center imaging study investigating the use of PET with 68Ga-citrate in patients with DLBCL or BCLU.
Detailed description
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.
Interventions
DRUGGallium 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.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed DLBCL or BCLU. * Double hit lymphoma, defined by positive cytogenetic/ fluorescence in situ hybridization (FISH) analysis for translocations involving myc and bcl2 or a double hit score of 2 by immunohistochemistry as described by Johnson et al. * DLBCL without myc translocation or overexpression by the above methods 2. Presence of palpable or radiographically measurable disease of at least 1.5 cm in longest dimension. 3. Available prior CT or PET/CT scan done in the last 8 weeks for comparison 4. Prior chemotherapy or radiation to the measurable lesion must be completed at least 14 days prior. 5. Adequate renal function with estimated creatinine clearance ≥50 mL/min (by the Cockcroft Gault equation) 6. No contraindications to MRI (e.g. pacemaker, aneurysm clips, severe claustrophobia) 7. Ability to sign a study-specific internal review board (IRB) approved consent prior to study entry. Patients must be able and willing to consent and undergo study procedures. 8. Age ≥18 years old
Exclusion criteria
1. Any serious and/or unstable pre-existing medical, psychiatric, or other medical condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedures 2. Body weight over 300 pounds 3. Female patients who are pregnant or breast-feeding 4. Prior MRI with gadolinium performed \<24 hours before the study scan 5. No red blood cell transfusion or iron administration by any route in the last 7 days 6. Prior hypersensitivity or intolerance to gadolinium or gallium citrate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of radiotracer in tumor tissue | 16 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing Gallium citrate uptake | 16 months | 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 |
Outcome results
None listed