A Phase 1/2 Study to Evaluate the in Vivo Biodistribution, Radiation Dosimetry and a Preliminary Assessment of the Diagnostic Performance of [18F]BL40
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- To determine the tolerability of [18F]BL40
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Diffuse large B-Cell lymphoma
- •Multiple myeloma
- •Mantle cell lymphoma
- •Marginal zone lymphoma
- •Chronic lymphocytic leukemia/small cell lymphoma
- •Waldenström Macroglobulinemia
- •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).
排除标准
- •Pregnant or breast-feeding
- •Medically unstable (e.g., acute illness, unstable vital signs)
- •Unable to lie supine for the duration of imaging
- •Unable to provide written consent
- •Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
- •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.
- •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.
- •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.
结局指标
主要结局
To determine the tolerability of [18F]BL40
时间窗: 1 hour post injection, 2 hours post injection and 18-72 hours post injection
Occurrence of dose-limiting toxicities (DLTs) per protocol.
To determine the Absorbed doses (ADs) to normal organs and tumors per unit of administered activity of [18F]BL40
时间窗: 6 months
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)
To evaluate the proportion of participants with tumors shown by [18F]BL40 PET/CT
时间窗: 1 year
Proportion of patients with \[18F\]BL40 positive disease at core reading.
To determine Time Integrated Activity Coefficients for organ and tumor for [18F]BL40
时间窗: 6 months
Average time the activity spends in the organ or tumor, measured in units MBq·h/MBq
To determine the safety of [18F]BL40
时间窗: 1 hour post injection, 2 hours post injection and 18-72 hours post injection
Proportion of subjects with adverse events (AEs), Grade 3 or above AEs, drug-related AEs
次要结局
- The proportion of patients in whom [18F]BL40 and [18F]FDG detect disease(1 year)
- To compare the number of lesions identified in [18F]BL40 and [18F]FDG(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)(1 year)
- To assess reader confidence(1 year)
- To compare the lesions identified in [18F]BL40 and [18F]FDG(1 year)