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

Launched by BRITISH COLUMBIA CANCER AGENCY · Jan 16, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new imaging agent called 18F-BL40, which is used in a type of scan known as PET/CT. The goal is to better visualize certain types of cancers, like Diffuse Large B-Cell Lymphoma and Multiple Myeloma, which can be hard to detect and monitor. By using this new tracer, researchers hope to improve the way doctors can see and understand the extent of the disease without needing invasive procedures like biopsies.

To participate in this study, individuals must be 19 years or older and have a confirmed diagnosis of one of the specified cancers. They should also have a life expectancy of at least three months and meet certain health criteria. If eligible, participants can expect to undergo two PET/CT scans—one using the new tracer (18F-BL40) and another using a standard tracer (18F-FDG). This study is not yet recruiting, so interested individuals will need to wait for enrollment to begin.

Gender

ALL

Eligibility criteria

• 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.