Recruiting

18F-BL40 & 18F-FDGPreliminary Assessment of [18F]BL40 in PET/CT Scans

Sponsor:

British Columbia Cancer Agency

Code:

NCT06224309

Conditions

Diffuse Large B-cell Lymphoma

Multiple Myeloma

Mantle Cell Lymphoma

Marginal Zone Lymphoma

Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

18F-BL40 PET/CT

18F-FDG PET/CT

Routine Blood Draw - Phase 1 only

Study Details

Brief 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.

Conditions

Diffuse Large B-cell Lymphoma

Multiple Myeloma

Mantle Cell Lymphoma

Marginal Zone Lymphoma

Chronic Lymphocytic Leukemia

Study ID

NCT06224309

Start date

Jun 10, 2024

Status verified date

Sep, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Mar 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥19 years
2. Life expectancy ≥3 months
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
4. Participants 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

Exclusion Criteria:

1. Pregnant or breast-feeding
2. Medically unstable (e.g., acute illness, unstable vital signs)
3. Unable to lie supine for the duration of imaging
4. Unable to provide written consent
5. Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
6. Participants with a history of uncontrolled allergic reactions and/or known or expected hypersensitivity to the peptide diagnostic \[18F\]BL40 or any of its excipients.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

18F-BL40 PET/CT scan

Each subject will have two PET/CT scans, one using 18F-BL40 and the other using 18F-FDG. The 18F-BL40 radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada. 18F-FDG is considered standard care and has been approved by Health Canada.

Interventions

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.

Primary outcome measure

To determine the tolerability of [18F]BL40 [ Time Frame: 1 hour post injection, 2 hours post injection and 18-72 hours post injection ]
To determine the Absorbed doses (ADs) to normal organs and tumors per unit of administered activity of [18F]BL40 [ Time Frame: 6 months ]
To evaluate the proportion of participants with tumors shown by [18F]BL40 PET/CT [ Time Frame: 1 year ]
To determine Time Integrated Activity Coefficients for organ and tumor for [18F]BL40 [ Time Frame: 6 months ]
To determine the safety of [18F]BL40 [ Time Frame: 1 hour post injection, 2 hours post injection and 18-72 hours post injection ]

Central Contacts and Locations

Central contacts

Pav Ravi

6048776000 pavithraa.ravi@bccancer.bc.ca

Heather Saprunoff

6048776000 hsaprunoff@bccancer.bc.ca

Locations

BC Cancer

Recruiting

Vancouver, British Columbia, Canada, V5Z4E6

Contacts

Pavithraa Ravi

6048776000 pavithraa.ravi@bccancer.bc.ca

Heather Saprunoff

6048776000 hsaprunoff@bccancer.bc.ca

Principal Investigator:

Ian Alberts

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.