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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Withdrawn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
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

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

    First Posted
    May 17, 2016
    Last Updated
    October 8, 2019
    Sponsor
    University of California, San Francisco
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    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

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