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

NCT ID: NCT02776891

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-13
• Study Completion Date: 2018-04-09

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.

Conditions

Lymphoma, Large B-Cell, Diffuse; Burkitt Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gallium citrate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Ga-68 citrate

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Evans, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Other Identifiers

16251

Identifier Type: -

Identifier Source: org_study_id