Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
研究概览
简要总结
This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.
详细描述
Eligible participants had previously received a bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP) as part of their regular medical care.
18F-NaF and 18F-FDG are radioactive substances (radiolabels) that are absorbed by cancerous cells and allow for the cancer to be found using diagnostic procedures such as positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI). PET/WBMRI is a combination procedure that combines the detailed PET images of areas inside the body from PET with the WBMRI scans, and may help find and diagnose skeletal metastases in patients with breast or prostate cancer. It is not yet known whether 18F-NaF/18F-FDG PET/WBMRI is better than standard imaging methods in detecting skeletal metastases.
Eligible participants diagnosed with breast/prostate cancers and who have had 99mTc MDP bone scanning as part of their routine care are recruited and enrolled. Participants then receive an 18F-NaF/18F-FDG positron emission tomography (PET)/ WBMRI combination scan.
The PET/MRI scans will be interpreted by 2 American Board Nuclear Medicine (ABNM)-certified physicians and 2 American Board of Radiology (ABR)-certified radiologists, all with significant clinical experience, who are blinded to the subjects' medical history and the results of other imaging modalities.
The scans will be analyzed and compared against each other, with a consensus read will be obtained for each scan. Characterization of lesions as true-positive, true-negative, false-positive or false-negative will be done through a combination of clinical follow-up, imaging follow-up and/or histopathology findings. An overall diagnosis based on each scan will be determined on a 5-point scale (1=benign, 2=likely benign, 3=uncertain, 4=likely malignant, 5=malignant) to conduct a receiver operating characteristic (ROC) analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
干预措施: Bone scan (Procedure)
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
干预措施: 99mTc-methyl diphosphonate (Drug)
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
干预措施: Positron Emission Tomography (PET) scan (Procedure)
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
干预措施: 18F-Fludeoxyglucose (18F-FDG) (Drug)
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
干预措施: Computed Tomography (CT) scan (Procedure)
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
干预措施: 18F-Sodium Fluoride (18F-NaF) (Drug)
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Preliminary pilot assessment to confirm feasibility & improved diagnostic accuracy of the combined 18F-NaF CT & 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
干预措施: Gadopentetate dimeglumine (Drug)
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
干预措施: Bone scan (Procedure)
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
干预措施: 99mTc-methyl diphosphonate (Drug)
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
干预措施: Positron Emission Tomography (PET) scan (Procedure)
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan
Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
干预措施: 99mTc-methyl diphosphonate (Drug)
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
干预措施: 18F-Fludeoxyglucose (18F-FDG) (Drug)
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
干预措施: Computed Tomography (CT) scan (Procedure)
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
干预措施: 18F-Sodium Fluoride (18F-NaF) (Drug)
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
干预措施: Whole Body Magnetic Resonance Imaging (WB-MRI) scan (Procedure)
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
干预措施: Gadofosveset (Drug)
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET scans
Assessment to define the accuracy of the combined 18F-NaF CT & 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
干预措施: Gadobutrol (Drug)
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan
Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
干预措施: Bone scan (Procedure)
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan
Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
干预措施: Positron Emission Tomography (PET) scan (Procedure)
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan
Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
干预措施: 18F-Fludeoxyglucose (18F-FDG) (Drug)
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan
Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
干预措施: 18F-Sodium Fluoride (18F-NaF) (Drug)
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan
Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
干预措施: Whole Body Magnetic Resonance Imaging (WB-MRI) scan (Procedure)
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan
Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
干预措施: Gadofosveset (Drug)
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI scan
Assessment to define the utility of 18F-NaF & 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
干预措施: Gadobutrol (Drug)
结局指标
主要结局
Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
时间窗: 30 days
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF \> 99mTc-MDP"), the same between both scans ("18F-NaF = 99mTc-MDP"), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF \< 99mTc-MDP").
次要结局
- Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT(30 days)
- Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT(30 days)
- Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT(30 days)
- Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions(30 days)
- Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions(30 days)
- Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI(30 days)
- Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT(30 days)
- Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI(30 days)
- Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions(30 days)
- Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy(30 days)
- Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI(30 days)
研究者
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Stanford University