Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Disease progression on CT and/or WB-MRI
研究概览
简要总结
This trial is a feasibility study prior to a planned phase III trial. Currently, assessing response to treatment of metastatic breast cancer in the bone is limited by the technical problems associated with CT scans and bone scans. WB-MRI provides theoretical and practical advantages that allow for more detailed analysis of disease response or progression. This may allow for earlier identification of progressive disease and earlier change in treatment.
Participants in the study will have a CT scan, bone scan and WB-MRI at baseline and then repeated CT and WB-MRI scans every 12 weeks (until week 96, and then every 24 weeks) until there is evidence of progressive disease on either of the imaging modalities. In addition to the regular scans on the study, patients will be given the opportunity to participate in a study of how reproducible the findings of WB-MRI scans are. At the point of disease progression, a repeat bone scan is performed and the involvement of the patient in the trial comes to an end.
详细描述
Patients are eligible for RESPECT if they have bone-only metastatic breast cancer (MBC), as established by standard CT and bone scintigraphy, and are starting a new line of systemic therapy. This can be first line SACT or any subsequent line.
All patients undergo a baseline CT scan (thorax/abdomen/pelvis) and isotope bone scan prior to commencing their new systemic therapy. All CT and bone scans are performed according to standard departmental protocols, with no deviations required. WB-MRI are performed within 2 weeks of study entry. CT scans and WB-MRI are then performed every 12 weeks until week 96, and then every 24 weeks until the patient completes the study. The reporting radiologist who interprets the CT scans is blinded to the images and results of the WB-MRI scan and vice versa.
At study commencement Participants are required to have had a CT scan of the thorax, abdomen and pelvis and a bone scan (bone scintigraphy with technetium-99m-methylene diphosphonate) no more than 4 weeks prior to trial entry to ensure that they have bony-only metastatic disease, as defined using standard imaging. Baseline WB-MRI scans are performed within 2 weeks of entry into the study.
Participants are assessed in clinic and a baseline physical examination is undertaken. Any additional tests required for the initiation of the new SACT are performed at the discretion of the treating clinician and according to local protocols.
During the study CT scans and WB-MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in the study protocol). Scans are performed within the range of 7 days prior and 7 days after the planned 12 weekly scan interval date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The reporting radiologist of the WB-MRI will be blinded to the results of the CT. The reporting radiologist of the CT will also be blinded to the results of the WB-MRI. Neither treating clinicians nor patients will be blinded at any point.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of breast cancer
- •Single or multiple bone metastases (no extraosseous or non-bony metastatic disease permitted)
- •Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted)
- •Aged 18 and over
- •Life expectancy of over 6 months
- •No current active malignancy other than breast cancer
- •Written informed consent must be given according to GCP, and national/local regulations
排除标准
- •Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis
- •Absolute contraindication to MRI studies, CT scans or bone scans
- •Pregnancy
- •Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient before registration in the trial before patient registration.
研究组 & 干预措施
WB-MRI sub-study group
Patients will be given the opportunity to participate in a sub-study of WB-MRI reproducibility. This involves a repeat scan of the Whole Body Magnetic Resonance Imaging (WB-MRI) diffusion-weighted sequences. This will be shorter in duration than the full WB-MRI scan and will take place within one hour of completing the full WB-MRI scan.
干预措施: Whole Body Magnetic Resonance Imaging (Diagnostic Test)
Main study group
Patients will have repeat CT (Computerised Tomography) scans and WB-MRI (Whole Body Magnetic Resonance Imaging) every 12 weeks until disease progression. A baseline bone scan (99mTc-MDP) will be performed.
At the point of disease progression, a repeat bone scan will be obtained in addition to the CT and WB-MRI.
干预措施: Computerised Tomography (Diagnostic Test)
Main study group
Patients will have repeat CT (Computerised Tomography) scans and WB-MRI (Whole Body Magnetic Resonance Imaging) every 12 weeks until disease progression. A baseline bone scan (99mTc-MDP) will be performed.
At the point of disease progression, a repeat bone scan will be obtained in addition to the CT and WB-MRI.
干预措施: Whole Body Magnetic Resonance Imaging (Diagnostic Test)
Main study group
Patients will have repeat CT (Computerised Tomography) scans and WB-MRI (Whole Body Magnetic Resonance Imaging) every 12 weeks until disease progression. A baseline bone scan (99mTc-MDP) will be performed.
At the point of disease progression, a repeat bone scan will be obtained in addition to the CT and WB-MRI.
干预措施: Bone scan (Diagnostic Test)
结局指标
主要结局
Disease progression on CT and/or WB-MRI
时间窗: Up to 96 weeks (from date of consent until the date of first documented progression)
Description of the metric used to characterize the specific primary outcome measure, if not included in the primary outcome measure title.
次要结局
- Disease progression on CT and/or WB-MRI(Up to 96 weeks (from date of consent until the date of first documented progression))