Preliminary Assessment of [18F]BL40 in PET/CT Scans

Condition(s) studied

Investigational drug(s) / intervention(s)

18F-BL40 PET/CT: Phase 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: The 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: Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after 18F-BL40 administration.

Study summary

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.

Eligibility

Primary outcome measure(s)

• To determine the tolerability of [18F]BL40 — 1 hour post injection, 2 hours post injection and 18-72 hours post injection
  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 — 6 months
  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 — 1 year
  Proportion of patients with \[18F\]BL40 positive disease at core reading.
• To determine Time Integrated Activity Coefficients for organ and tumor for [18F]BL40 — 6 months
  Average time the activity spends in the organ or tumor, measured in units MBq·h/MBq
• To determine the safety of [18F]BL40 — 1 hour post injection, 2 hours post injection and 18-72 hours post injection
  Proportion of subjects with adverse events (AEs), Grade 3 or above AEs, drug-related AEs

Trial sites (1)

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