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
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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lymphoma, Large B-Cell, Diffuse
Burkitt Lymphoma
Keywords: lymphoma
gallium citrate
PET
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Uptake of radiotracer in tumor tissue
timeFrame: 16 months
Secondary outcomes:
measure: Comparing Gallium citrate uptake
timeFrame: 16 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Michael Evans, MD
role: PRINCIPAL_INVESTIGATOR
References: