Monitoring Early Response to Targeted Therapy in Stage IV Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Patients With Advanced Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Baseline measure of signal enhancement ratio (SER) from MRI.
研究概览
简要总结
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.
详细描述
The purpose of this study is to see if a new group of imaging tests can help identify response to stage IV human epidermal growth factor receptor 2 positive (HER2+) breast cancer before and during treatment. This study will test a new method for monitoring treatment. The investigators will use [18F]-Fluorodeoxyglucose (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) to look at previously diagnosed stage IV breast cancer and image up to three times during therapy. FDG is a non-natural amino acid with a radioactive tag that is used clinically for staging of disease. However, the role of FDG-PET/MRI for imaging response in breast cancer is not currently clear. PET/MRI is a new imaging technique that combines PET and MRI into a single study.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥ 18 years old and ≤ 75 years old
- •Patients with HER2+ metastatic breast cancer
- •HER2-positive breast cancer prospectively determined on the primary tumor by a local pathology laboratory and defined as immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility
- •Estrogen/progesterone receptor positive OR negative disease allowed
- •Patients must have measurable disease in one metastatic lesion per RECIST v 1.1
- •Stage IV HER2+ breast cancer patients eligible for a new therapeutic regimen that includes HER2-targeted treatment who are naïve to that regimen
- •Estimated life expectancy of greater than six months
排除标准
- •Children, less than 18 years of age, will be excluded from this study
- •Metastatic breast cancer patients who are HER2 positive and have already started their current HER2-targeted therapy regimen for metastatic disease
- •Patients who have not recovered from grade 2 or higher toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment
- •Patient is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment
- •Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection that requires systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).
- •Patients found to have constitutionally present non-magnetic resonance (MR) compatible ferromagnetic materials
- •Unable to lie still on the imaging table for one (1) hour
- •Inability to receive gadolinium-based contrast agent
- •Patients for whom a PET/MRI is technically not feasible (e.g. breast volume, obesity, > body mass index (BMI) 36)
研究组 & 干预措施
[18F]-Fluorodeoxyglucose (FDG) PET/ MRI
干预措施: [18F]-FDG (Drug)
结局指标
主要结局
Baseline measure of signal enhancement ratio (SER) from MRI.
时间窗: Baseline imaging visit 1
Compare baseline metrics from PET/MRI
Changes in SER from MRI
时间窗: Baseline through 6 months
Compare percent change of SER from imaging visit 3 to the baseline.
Changes in ADC from MRI
时间窗: Baseline through 6 months
Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.
Baseline measure of PET standardized uptake value (SUV).
时间窗: Baseline imaging visit 1
Compare baseline metrics from PET/MRI
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
时间窗: Baseline imaging visit 1
Compare baseline metrics from PET/MRI
Changes in SUV from PET
时间窗: Baseline through 6 months
Compare percent change of SUV from imaging visit 3 to the baseline.
次要结局
- Changes in ADC (mm2/sec) from MRI.(Baseline through 2 months)
- Changes in SER from MRI.(Baseline through 2 months)
- Follow-up(Baseline through 5 year follow-up)
- Changes in SUV from PET.(Baseline through 2 months)
研究者
Anna G. Sorace
Assistant Professor, Department of Radiology and Biomedical Engineering Director, The Small Animal Facility in the Advanced Medical Imaging Research Division
University of Alabama at Birmingham