Clinical trial NCT06224309: Preliminary Assessment of [18F]BL40 in PET/CT Scans
Official title: A Phase 1/2 Study to Evaluate the in Vivo Biodistribution, Radiation Dosimetry and a Preliminary Assessment of the Diagnostic Performance of [18F]BL40
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diffuse Large B-cell Lymphoma
Multiple Myeloma
Mantle Cell Lymphoma
Marginal Zone Lymphoma
Chronic Lymphocytic Leukemia
Waldenström Macroglobulinemia
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This will be a prospective, open-label trial in patients 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

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.

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.

Primary outcomes:
measure: To determine the tolerability of [18F]BL40
timeFrame: 1 hour post injection, 2 hours post injection and 18-72 hours post injection
measure: To determine the Absorbed doses (ADs) to normal organs and tumors per unit of administered activity of [18F]BL40
timeFrame: 6 months
measure: To evaluate the proportion of participants with tumors shown by [18F]BL40 PET/CT
timeFrame: 1 year
measure: To determine Time Integrated Activity Coefficients for organ and tumor for [18F]BL40
timeFrame: 6 months
measure: To determine the safety of [18F]BL40
timeFrame: 1 hour post injection, 2 hours post injection and 18-72 hours post injection
Secondary outcomes:
measure: The proportion of patients in whom [18F]BL40 and [18F]FDG detect disease
timeFrame: 1 year
measure: To compare the number of lesions identified in [18F]BL40 and [18F]FDG
timeFrame: 1 year
measure: To assess tumour detectability and image quality by means of standardised uptake values (SUV) for tumour lesions in [18F]BL40 compared to 2[18F]FDG PET/CT (SUVmax, SUVpeak, tumour to background ratio for liver, blood, and lung, contrast to noise ratio)
timeFrame: 1 year
measure: To compare the lesions identified in [18F]BL40 and [18F]FDG
timeFrame: 1 year
measure: To assess reader confidence
timeFrame: 1 year
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer
state: British Columbia
Study officials:
affiliation: BC Cancer
name: Ian Alberts
role: PRINCIPAL_INVESTIGATOR
References: