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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-BL40 PET/CT | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the tolerability of [18F]BL40 | Occurrence of dose-limiting toxicities (DLTs) per protocol. | 1 hour post injection, 2 hours post injection and 18-72 hours post injection |
| To determine the Absorbed doses (ADs) to normal organs and tumors per unit of administered activity of [18F]BL40 | Absorbed doses (ADs) to organs and tumors per unit of administered activity is measured in units Gy/MBq. (Tumor, individual organ dose and whole-body effective dose) | 6 months |
| To evaluate the proportion of participants with tumors shown by [18F]BL40 PET/CT | Proportion of patients with [18F]BL40 positive disease at core reading. | 1 year |
| To determine Time Integrated Activity Coefficients for organ and tumor for [18F]BL40 | Average time the activity spends in the organ or tumor, measured in units MBq·h/MBq | 6 months |
| To determine the safety of [18F]BL40 | Proportion of subjects with adverse events (AEs), Grade 3 or above AEs, drug-related AEs | 1 hour post injection, 2 hours post injection and 18-72 hours post injection |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients in whom [18F]BL40 and [18F]FDG detect disease | The proportion of patients in whom one or more target lesions are detected by the core readers | 1 year |
| To compare the number of lesions identified in [18F]BL40 and [18F]FDG |
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Inclusion Criteria:
Age ≥19 years
Life expectancy ≥3 months
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Participants with newly diagnosed or documented recurrent malignancy with one of the following cancers:
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:
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This will be a prospective, open-label trial in patients with newly diagnosed or documented recurrent malignancy with one of the following cancers:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Alberts | BC Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer | Vancouver | British Columbia | V5Z4E6 | Canada |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D009101 | Multiple Myeloma |
| D020522 | Lymphoma, Mantle-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| 18F-FDG PET/CT | 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 | Diagnostic Test | Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after 18F-BL40 administration. |
|
Scan features for comparison may include, but are not limited to:
Total number of lesions detected
| 1 year |
| 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) | Standard Uptake Values (SUV) mean SUV maximum SUV peak SUV Tumor tissue to Background tissue ratio, Tumor/blood; Tumor/Liver; Tumor/ kidney | 1 year |
| To compare the lesions identified in [18F]BL40 and [18F]FDG | Scan features for comparison may include, but are not limited to: Site of lesions | 1 year |
| To assess reader confidence | Diagnostic confidence on a three-point scale (high, moderate and low) | 1 year |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |