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Withdrawn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
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphoma, Large B-Cell, Diffuse focused on measuring lymphoma, gallium citrate, PET
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.
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
No
Product Manufactured in and Exported from the U.S.
No
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
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.
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
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.
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
No
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
No
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
We'll reach out to this number within 24 hrs