CXCR4 is type of receptor that has been detected in more than twenty different subtypes of cancers. Most of these cancers are associated with negative symptoms that worsen over time resulting in great disability and poor function. There is a need for novel tracers to image CXCR4-expressing tumors for better detection, staging, and monitoring of aggressive cancers without the need for invasive biopsy procedures that may not always properly capture the extent of a patient's disease.
This study looks to assess the safety and efficacy of a novel radiopharmaceutical known as 18F-BL40 through its use in a PET/CT scan. Participants will receive 2 PET/CT scans:
18F-BL40 and 18F-FDG as part of this study.
Age ≥19 years
Life expectancy ≥3 months
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Diffuse large B-Cell lymphoma
Pregnant or breast-feeding
Medically unstable (e.g., acute illness, unstable vital signs)
Unable to lie supine for the duration of imaging
Unable to provide written consent
This will be a prospective, open-label trial in patients with newly diagnosed or documented recurrent malignancy with one of the following cancers: * Diffuse large B-Cell lymphoma * Multiple myeloma * Mantle cell lymphoma * Marginal zone lymphoma * Chronic lymphocytic leukemia/small cell lymphoma * Waldenström Macroglobulinemia
Cohort
Prospective
18F-BL40 PET/CT
Diagnostic testPhase 1 (Patients 1-10): Vital signs will be recorded prior to the BL40 injection. Each study subject will have an intravenous catheter inserted. Prior to the radiotracer injection an ultra low dose CT will be taken. The subject will receive a bolus intravenous dose of the 18F-BL40. A Dynamic PET scan will be taken of the heart followed by serial whole body PET scan will be done. Vital signs will be taken again and the subject will have a bathroom break. The patient will return to the scanner bed for a standard low dose CT and whole body PET scan. Vital signs will be taken again, and subject will be allowed to use the washroom again. The subject will return to the scanner bed for the final time for an ultra low dose CT and whole body PET scan. A final set of vitals will be taken and the subject will be discharged. Phase 2 (11-30): IV bolus dose of BL40, 1 hours uptake time followed by 15-minute static scan. No vital signs taken.
18F-FDG PET/CT
Diagnostic testThe patient will return on another day for the 18F-FDG PET/CT scan. A fasting period of 6 hours is required before this scan. Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site. The subject will rest in a comfortable chair for 60 minutes. The subjects will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired.
Routine Blood Draw - Phase 1 only
Diagnostic testComplete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after 18F-BL40 administration.
To determine the tolerability of [18F]BL40
Occurrence of dose-limiting toxicities (DLTs) per protocol.
To determine the Absorbed doses (ADs) to normal organs and tumors per unit of administered activity of [18F]BL40
Absorbed doses (ADs) to organs and tumors per unit of administered activity is measured in units Gy/MBq. (Tumor, individual organ dose and whole-body effective dose)
To evaluate the proportion of participants with tumors shown by [18F]BL40 PET/CT
Proportion of patients with \[18F\]BL40 positive disease at core reading.
To determine Time Integrated Activity Coefficients for organ and tumor for [18F]BL40
Average time the activity spends in the organ or tumor, measured in units MBq·h/MBq
The proportion of patients in whom [18F]BL40 and [18F]FDG detect disease
The proportion of patients in whom one or more target lesions are detected by the core readers
To compare the number of lesions identified in [18F]BL40 and [18F]FDG
Scan features for comparison may include, but are not limited to: Total number of lesions detected
To assess tumour detectability and image quality by means of standardised uptake values (SUV) for tumour lesions in [18F]BL40 compared to 2[18F]FDG PET/CT (SUVmax, SUVpeak, tumour to background ratio for liver, blood, and lung, contrast to noise ratio)
Standard Uptake Values (SUV) mean SUV maximum SUV peak SUV Tumor tissue to Background tissue ratio, Tumor/blood; Tumor/Liver; Tumor/ kidney
To compare the lesions identified in [18F]BL40 and [18F]FDG
Scan features for comparison may include, but are not limited to: Site of lesions
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