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

NCT ID: NCT06224309

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2025-10-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

18F-BL40 PET/CT

Intervention Type: DIAGNOSTIC_TEST

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. Subjects are positioned supine, arms down. The subject will receive a bolus intravenous dose of the 18F-BL40 from an approved study supplier site. A Dynamic PET scan will be taken of the heart. Then a 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.

18F-FDG PET/CT

Intervention Type: DIAGNOSTIC_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 only

Intervention Type: DIAGNOSTIC_TEST

Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after 18F-BL40 administration.

Interventions

18F-BL40 PET/CT

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. Subjects are positioned supine, arms down. The subject will receive a bolus intravenous dose of the 18F-BL40 from an approved study supplier site. A Dynamic PET scan will be taken of the heart. Then a 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.

Intervention Type: DIAGNOSTIC_TEST

18F-FDG PET/CT

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.

Intervention Type: DIAGNOSTIC_TEST

Routine Blood Draw - Phase 1 only

Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after 18F-BL40 administration.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Columbia Cancer Agency

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Alberts

Role: PRINCIPAL_INVESTIGATOR

BC Cancer

Locations

BC Cancer

Vancouver, British Columbia, Canada

Countries

Canada

Central Contacts

Pav Ravi

Role: CONTACT

pavithraa.ravi@bccancer.bc.ca

6048776000 ext. 2818

Heather Saprunoff

Role: CONTACT

hsaprunoff@bccancer.bc.ca

6048776000 ext. 2818

Facility Contacts

Pav Ravi

Role: primary

pavithraa.ravi@bccancer.bc.ca

6048776000 ext. 2818

Heather Saprunoff

Role: backup

hsaprunoff@bccancer.bc.ca

6048776000 ext. 2818

Other Identifiers

H23-03813

Identifier Type: -

Identifier Source: org_study_id