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

British Columbia Cancer Agency

Status: Not yet enrolling

Conditions: Waldenström Macroglobulinemia; Multiple Myeloma; Marginal Zone Lymphoma; Mantle Cell Lymphoma; Diffuse Large B-cell Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Diagnostic Test: 18F-FDG PET/CT; Diagnostic Test: Routine Blood Draw - Phase 1 only; Diagnostic Test: 18F-BL40 PET/CT

Study type: Observational

Funder types: Other

Identifiers

NCT06224309

H23-03813

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

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.

Treatment:

Diagnostic Test: Routine Blood Draw - Phase 1 only

Diagnostic Test: 18F-BL40 PET/CT

Diagnostic Test: 18F-FDG PET/CT