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

A Feasibility Study of Gallium-68 Citrate PET to Detect Aberrant MYC Protein Expression in Diffuse Large B-Cell Lymphoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Large B-Cell, Diffuse
• Burkitt Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-06-13
• Primary completion: 2018-04-09
• Completion: 2018-04-09
• First posted: 2016-05-18
• Last updated: 2019-10-10

Regulatory

• FDA-regulated drug study