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

Phase 2

Withdrawn

• Conditions: Lymphoma, Large B-Cell, Diffuse; Burkitt Lymphoma
• Interventions: Drug: Gallium citrate

• Registration Number: NCT02776891
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Study Start: 2016-06-13
• Primary Completion: 2018-04-09
• Study Completion: 2018-04-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-08
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gallium citrate	Gallium citrate	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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