Search / Trial NCT06224309

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

Launched by BRITISH COLUMBIA CANCER AGENCY · Jan 16, 2024

Trial Information

Current as of October 04, 2024

Not yet recruiting

Keywords

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 ...

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.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Vancouver, British Columbia, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0