Diffuse Large B-cell LymphomaNCT06224309
Preliminary Assessment of [18F]BL40 in PET/CT Scans
An observational study of Diffuse Large B-cell Lymphoma and Multiple Myeloma, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma, Multiple Myeloma, Mantle Cell Lymphoma
- What is being tested?
- 18F-BL40 PET/CT, 18F-FDG PET/CT and Routine Blood Draw - Phase 1 only
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2024to 15 Sep 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 10Show fewer
- Mantle cell lymphoma
- Marginal zone lymphoma
- Chronic lymphocytic leukemia/small cell lymphoma
- Waldenström Macroglobulinemia
Who cannot join
- 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 a history of uncontrolled allergic reactions and/or known or expected hypersensitivity to the peptide diagnostic [18F]BL40 or any of its excipients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
BC Cancer
Vancouver, British Columbia, V5Z4E6
Pavithraa Ravi, 6048776000 ext. 2818, pavithraa.ravi@bccancer.bc.ca
Heather Saprunoff, 6048776000 ext. 2818, hsaprunoff@bccancer.bc.ca
About this study
Official title: A Phase 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.
Read the 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.
- Conditions
- Diffuse Large B-cell Lymphoma, Multiple Myeloma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, Waldenström Macroglobulinemia
- Being tested
- 18F-BL40 PET/CT, 18F-FDG PET/CT, Routine Blood Draw - Phase 1 only
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Multiple Myeloma, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-BL40 PET/CTDiagnostic test
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/CTDiagnostic test
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 onlyDiagnostic test
Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after 18F-BL40 administration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 18F-BL40 PET/CT; Diagnostic Test: 18F-FDG PET/CT; Diagnostic Test: Routine Blood Draw - Phase 1 only |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the tolerability of [18F]BL40
Occurrence of dose-limiting toxicities (DLTs) per protocol.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 6 months
To determine the safety of [18F]BL40
Proportion of subjects with adverse events (AEs), Grade 3 or above AEs, drug-related AEs
Measured: 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
The proportion of patients in whom one or more target lesions are detected by the core readers
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
To assess reader confidence
Diagnostic confidence on a three-point scale (high, moderate and low)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start10 Jun 2024
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Alberts, Principal investigator, BC Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224309
- Sponsor's protocol ID
- H23-03813
- Status last verified
- Sep 2026
- First submitted
- 27 Dec 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No