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

A Phase 1/2 Study to Evaluate the in Vivo Biodistribution, Radiation Dosimetry and a Preliminary Assessment of the Diagnostic Performance of [18F]BL40

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma; Waldenström Macroglobulinemia; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Chronic Lymphocytic Leukemia; Diffuse Large B-cell Lymphoma
• Intervention / Treatment: Diagnostic test: 18F-BL40 PET/CT; Diagnostic test: 18F-FDG PET/CT; Diagnostic test: Routine Blood Draw - Phase 1 only

Detailed Description

This is a prospective registry study to evaluate the diagnostic utility of 18F-BL40 PET/CT to stage patients with CXCR4-expressing tumors, localize sites of tumors and assess safety and biodistribution of this drug in PET/CT scans.

Each subject will receive 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.

Follow-up assessments: All subjects will be contacted by phone the day after the injection of 18F-BL40. The subjects will be asked if they experienced any undesirable effects during the 18-72 hours after the administration of 18F-BL40. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 18F-BL40 administration.

All subjects will be followed for at least 6 months following the 18F-BL40 PET/CT exam. The evaluation will include a chart review of available imaging, laboratory tests, and treatment. The data required can be obtained from a review of the patient's paper and electronic charts, supplemented by telephone contact as needed to complete the information.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z4E6
      • BC Cancer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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
5. For all indications except multiple myeloma, the participants at the time of enrolment must either be at initial presentation with histologically confirmed lymphoma, or have the presence of measurable disease by computed tomography (CT) and/or magnetic resonance imaging (MRI) or at least one visualized lesion on positron emission tomography (PET)/CT imaging (from an [18F]FDG PET) within 60 days of enrolment. In the case of participants with multiple myeloma, there must be documented relapse or progressive disease by MRI or [18F]FDG PET/CT imaging, or measurable disease within 60 days of enrolment (serum M-protein ≥0.5 g/dL or urine Bence-Jones protein ≥200 mg/24 hours).

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 widespread liver metastases occupying more than 50% of the liver volume will not be eligible to participate in this study as this would preclude assessment of normal liver activity for dosimetry purposes.
7. Participants who have received chemotherapy or dexamethasone (> 4 mg/day) within 3 weeks or antibody therapy within 6 weeks prior to the [18F]BL40 or [18F]FDG PET/CT scans.
8. Participants who have received radiotherapy in the previous 6 weeks prior to [18F]BL40 or [18F]FDG PET/CT scans to sites of measurable active disease.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: 18F-BL40 PET/CT; 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. Subjects are positioned supine, arms down. The subject will receive a bolus intravenous dose of the 18F-BL40 from an approved study supplier site. A Dynamic PET scan will be taken of the heart. Then a 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.; Diagnostic test: 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.; Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
To determine the tolerability of [18F]BL40	Occurrence of dose-limiting toxicities (DLTs) per protocol.	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	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)	6 months
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	6 months
To determine the safety of [18F]BL40	Proportion of subjects with adverse events (AEs), Grade 3 or above AEs, drug-related AEs	1 hour post injection, 2 hours post injection and 18-72 hours post injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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	1 year
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	1 year
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	1 year
To assess reader confidence	Diagnostic confidence on a three-point scale (high, moderate and low)	1 year

Collaborators and Investigators

• Sponsor: British Columbia Cancer Agency
• Investigators: Principal Investigator: Ian Alberts, BC Cancer

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): February 14, 2025

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Lymphoma, B-Cell; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Lymphoma, Large B-Cell, Diffuse; Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Myeloma; Lymphoma, Mantle-Cell; Waldenstrom Macroglobulinemia; Lymphoma, B-Cell, Marginal Zone; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: H23-03813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No