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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

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ClinicalTrials.gov Identifier: NCT02776891
Recruitment Status : Withdrawn (Unexpected dose production issues prevented study start up)
First Posted : May 18, 2016
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : June 13, 2016
Actual Primary Completion Date : April 9, 2018
Actual Study Completion Date : April 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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 Name: Ga-68 citrate


Outcome Measures
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Primary Outcome Measures :
  1. Uptake of radiotracer in tumor tissue [ Time Frame: 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 :
  1. Comparing Gallium citrate uptake [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776891


Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Michael Evans, MD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02776891    
Other Study ID Numbers: 16251
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of California, San Francisco:
lymphoma
gallium citrate
PET
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Epstein-Barr Virus Infections
Herpesviridae Infections
 DNA Virus Infections
Virus Diseases
Infections
Tumor Virus Infections
Citric Acid
Sodium Citrate
Gallium citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals