Pilot Study of Multi-Modality Imaging in Patients With Hematologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Percentage of Proliferating Bone Marrow in the Femur
研究概览
简要总结
This is a pilot sub-study of patients receiving myeloablative transplant using total body irradiation (TBI) or total marrow irradiation (TMI) in their preparative regimen. The objective of this stub-study is to estimate the heterogeneity in cellular proliferation (FLT-PET uptake) as well the heterogeneity in marrow composition distribution (measured using whole body water-fat MRI) using positron emission tomography imaging. This will be used to design future trials as well as to determine the feasibility of PET and MRI imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of hematologic malignancy and fitting into one of the following categories:
- •Newly diagnosed and/or day 14 post-induction chemotherapy
- •Relapsed, including relapse after hematopoietic cell transplant
- •Planned hematopoietic cell transplant (if enrolling at "close") or within 100 days post hematopoietic cell transplant (if enrolling post-transplant) with a preparative regimen that includes either total marrow irradiation (TMI) or total body irradiation (TBI)
- •Undergoing natural killer cell therapies (with or without subsequent transplant)
- •Aged 18 years and older
- •Not pregnant - women of childbearing potential will have a confirmatory pregnancy test prior to each imaging per routine procedures
- •Adequate renal function (estimated glomerular filtration rate > 60 ml/min) as determined by a serum creatinine level performed as a part of standard of care within 7 days of imaging
- •Able and willing to provide written consent
排除标准
- •Otherwise eligible patients meeting one or more of the contraindicates for an MRI, may enroll in the study without undergoing the MRI:
- •ferromagnetic implants
- •history of shrapnel or shot gun injury
- •too large to fit in the magnet (approximate body mass index ≥ 40)
- •cardiac pacemakers or other implanted devices that are not MR-compatible
- •claustrophobia
- •large tattoos
研究组 & 干预措施
Imaging studies
Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.
干预措施: FLT PET/CT (Radiation)
Imaging studies
Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.
干预措施: MRI (Device)
结局指标
主要结局
Percentage of Proliferating Bone Marrow in the Femur
时间窗: 100 days
The difference in the percentage of proliferating bone marrow between baseline and day 100 post transplant in the femur
Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days
时间窗: 100 days
The difference in percentage of proliferating bone marrow will be calculated for the following sites: skull, proximal humeri, ribs, clavicles, cervical spine, thoracic spine, lumbar spine, sacrum, pelvis and proximal femur.
Difference in Water Fat
时间窗: 100 days
The difference in the water-fat MRI between baseline and day 100 post transplant in L4 and femoral neck.
次要结局
未报告次要终点