A Feasibility Study of Gallium-68 Citrate PET to Detect Aberrant MYC Proto-Oncogene, BHLH Transcription Factor (MYC) Protein Expression in Diffuse Large B-Cell Lymphoma

University of California San Francisco (UCSF)

Status and phase: Withdrawn; Phase 2

Conditions: Lymphoma, Large B-Cell, Diffuse; Burkitt Lymphoma

Treatments: Drug: Gallium citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT02776891

16251

Details and patient eligibility

About

This is a single center imaging study investigating the use of PET with 68Ga-citrate in patients with DLBCL or BCLU.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Gallium citrate

Experimental group

Description:

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.

Treatment:

Drug: Gallium citrate