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
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedFebruary 9, 2024
January 1, 2024
7 months
December 27, 2023
February 7, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
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 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 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 Outcomes (5)
The proportion of patients in whom [18F]BL40 and [18F]FDG detect disease
1 year
To compare the number of lesions identified in [18F]BL40 and [18F]FDG
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)
1 year
To compare the lesions identified in [18F]BL40 and [18F]FDG
1 year
To assess reader confidence
1 year
Study Arms (1)
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
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.
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.
Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after 18F-BL40 administration.
Eligibility Criteria
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
You may qualify if:
- Age ≥19 years
- Life expectancy ≥3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- 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
- 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).
You may not qualify if:
- 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
- Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
- 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.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Cancer
Vancouver, British Columbia, V5Z4E6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Alberts
BC Cancer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2023
First Posted
January 25, 2024
Study Start
May 1, 2024
Primary Completion
December 1, 2024
Study Completion
October 1, 2025
Last Updated
February 9, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share