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

Sponsor

University of California, San Francisco (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02776891

Collaborator

(none)

Enrollment

Arm

21.8

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Large B-Cell, Diffuse Burkitt Lymphoma	Drug: Gallium citrate	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A Feasibility Study of Gallium-68 Citrate PET to Detect Aberrant MYC Protein Expression in Diffuse Large B-Cell Lymphoma

Actual Study Start Date :

Jun 13, 2016

Actual Primary Completion Date :

Apr 9, 2018

Actual Study Completion Date :

Apr 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: Ga-68 citrate

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

Ga-68 citrate

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Presence of palpable or radiographically measurable disease of at least 1.5 cm in longest dimension.
Available prior CT or PET/CT scan done in the last 8 weeks for comparison
Prior chemotherapy or radiation to the measurable lesion must be completed at least 14 days prior.
Adequate renal function with estimated creatinine clearance ≥50 mL/min (by the Cockcroft Gault equation)
No contraindications to MRI (e.g. pacemaker, aneurysm clips, severe claustrophobia)
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.
Age ≥18 years old

Exclusion Criteria:

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
Body weight over 300 pounds
Female patients who are pregnant or breast-feeding
Prior MRI with gadolinium performed <24 hours before the study scan
No red blood cell transfusion or iron administration by any route in the last 7 days
Prior hypersensitivity or intolerance to gadolinium or gallium citrate.