Preliminary Assessment of [18F]BL40 in PET/CT Scans (NCT06224309) | Clinical Trial Compass
CompletedNot Applicable
Preliminary Assessment of [18F]BL40 in PET/CT Scans
Canada10 participantsStarted 2024-06-10
Plain-language 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.
Who can participate
Age range
19 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a radioactive imaging agent called [18F]BL40 to detect tumors in conditions like mine — now that the study is completed, has the data shown that this tracer was safe and able to detect my type of lymphoma or myeloma reliably, and does that change how my doctor might approach my imaging going forward?
2Since this was a preliminary safety and dosing study rather than a treatment trial, does it mean the findings would mainly affect how I might be imaged in the future rather than directly changing my treatment options right now?
3The study measured how much radiation different organs absorb from [18F]BL40 — based on those findings, are there any safety concerns I should know about if I were ever to receive this type of scan as part of my care?
4Given that this trial enrolled patients with several different B-cell cancers including my specific diagnosis, is there published data I can review about how well [18F]BL40 detected tumors in patients with my condition compared to the standard PET scans I might already be getting?
5Now that this study is complete, are there follow-up trials planned that would test [18F]BL40 as an actual diagnostic tool, and would my doctor consider that a path worth exploring for my situation compared to standard imaging approaches?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the tolerability of [18F]BL40
Timeframe: 1 hour post injection, 2 hours post injection and 18-72 hours post injection
2
To determine the Absorbed doses (ADs) to normal organs and tumors per unit of administered activity of [18F]BL40
Timeframe: 6 months
3
To evaluate the proportion of participants with tumors shown by [18F]BL40 PET/CT
Timeframe: 1 year
4
To determine Time Integrated Activity Coefficients for organ and tumor for [18F]BL40
Timeframe: 6 months
5
To determine the safety of [18F]BL40
Timeframe: 1 hour post injection, 2 hours post injection and 18-72 hours post injection
. 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.