Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Waldenström Macroglobulinemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-BL40 PET/CT | Diagnostic Test | — | UNRESOLVED |
| 18F-FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
| Routine Blood Draw - Phase 1 only | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 18F-BL40 PET/CT scan
- description
- 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.
- interventionNames
- Diagnostic Test: 18F-BL40 PET/CT
- Diagnostic Test: 18F-FDG PET/CT
- Diagnostic Test: Routine Blood Draw - Phase 1 only
Primary outcomes (5)
- measure
- To determine the tolerability of [18F]BL40
- timeFrame
- 1 hour post injection, 2 hours post injection and 18-72 hours post injection
- description
- Occurrence of dose-limiting toxicities (DLTs) per protocol.
- measure
- To determine the Absorbed doses (ADs) to normal organs and tumors per unit of administered activity of [18F]BL40
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available