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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

Primary Purpose

Lymphoma, Large B-Cell, Diffuse, Burkitt Lymphoma

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Gallium citrate

About this trial

This is an interventional diagnostic trial for Lymphoma, Large B-Cell, Diffuse focused on measuring lymphoma, gallium citrate, PET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gallium citrate

Arm 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.

Outcomes

Primary Outcome Measures

Uptake of radiotracer in tumor tissue

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

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

Full Information

NCT ID

NCT02776891

First Posted

May 17, 2016

Last Updated

October 8, 2019

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT02776891

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Unexpected dose production issues prevented study start up

Study Start Date

June 13, 2016 (Actual)

Primary Completion Date

April 9, 2018 (Actual)

Study Completion Date

April 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Large B-Cell, Diffuse, Burkitt Lymphoma

Keywords

lymphoma, gallium citrate, PET

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Gallium citrate

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Gallium citrate

Other Intervention Name(s)

Ga-68 citrate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Uptake of radiotracer in tumor tissue

Description

Time Frame

16 months

Secondary Outcome Measure Information:

Title

Comparing Gallium citrate uptake

Description

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

Time Frame

16 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Evans, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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