TheranosticTrials.org

Clinical Trial · NCT02776891

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

Overview

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

Sponsor

University of California, San Francisco

Phase

Phase 2

Contacts

Michael Evans, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02776891

Eligibility

Inclusion

  • Presence of palpable or radiographically measurable disease of at least 1.5 cm in longest dimension.
  • 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)
  • Histologically confirmed DLBCL or BCLU.
  • 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.
  • No contraindications to MRI (e.g. pacemaker, aneurysm clips, severe claustrophobia)
  • DLBCL without myc translocation or overexpression by the above methods
  • Available prior CT or PET/CT scan done in the last 8 weeks for comparison
  • 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.

Exclusion

  • Body weight over 300 pounds
  • Prior hypersensitivity or intolerance to gadolinium or gallium citrate.
  • 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