PET Imaging of Chemotherapy-Induced Cardiotoxicity
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Changes in 68Ga-Galmydar Standardized Uptake Value (SUV) in patients with and without cardiotoxicity
研究概览
简要总结
This study is a single center, phase 1 clinical imaging study designed to assess the role of 68Ga-Galmydar Positron Emission Tomography (PET) imaging for detection of cardiotoxicity in human subjects with breast cancer or lymphoma undergoing treatment with anthracycline for cancer therapy.
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 21-99 years of age and any race
- •Normal left ventricular function (left ventricular ejection fraction (LVEF) >50%) as determined by echocardiography
- •HER2 positive or negative breast cancer patients or lymphoma patients
- •Designated to receive standard of care (SOC) treatment with an anthracycline-containing regimen including combination therapy
- •Patients willing to adhere to fasting for 15 hours before 18F-FDG PET imaging studies (if applicable)
排除标准
- •Inability to receive and sign informed consent
- •Prior exposure to anthracyclines or other cardiotoxic drug
- •Contraindications to anthracycline chemotherapy
- •Patients with history of myocardial infarction
- •Patients with fasting blood sugar >200 mg/dL or <70 mg/dL and symptomatic
- •Contraindications to MR imaging (ferromagnetic implants, pacemaker, brain aneurysm clips, shrapnel, claustrophobia, etc.)
- •Pregnant or lactating. All female subjects of childbearing potential must have a documented negative pregnancy test (serum or urine hCG) performed within 24 hours immediately prior to the administration of 68Ga-Galmydar or documented post-menopausal defined as the cessation of menses for ≥ 12 months or documentation of having a bilateral oophorectomy and/or hysterectomy.
- •Any condition that in the opinion of the Principal Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with collection of the data such as:
- •Inability to lie still or unable to tolerate a supine position with arms up over the head or down at sides for up to a 60-minute PET scan due to chronic back/shoulder pain or arthritis as assessed by physical examination and/or medical history
研究组 & 干预措施
68Ga-Galmydar + PET Imaging
Lymphoma patients: baseline prior to the start of chemotherapy treatment, after the patient has had at least 250 mg/m^2 of anthracycline (after the 5th cycle & before the 6th cycle of anthracycline in Non-Hodgkin lymphoma or after the 5th cycle (10 treatments) in Hodgkin lymphoma, 1-3 weeks after the 5th cycle of anthracycline), and 12-months (+/- 1 month) post-treatment
Breast patients: baseline prior to the start of all chemotherapy treatments, baseline after Paclitaxel and prior to the start of AC (Adriamycin & Cyclophosphamide) for patients treated with the Keynote-522 regimen, 1-2 weeks after the last dose (4 cycles) of AC, and 12-months (+/- 1 month) post-treatment
Echocardiography will be performed at all PET imaging sessions & at 6- and 9-months post-chemotherapy
A subset of 3 breast & 3 lymphoma patients will undergo 18F-FDG PET/MRI. Patients undergoing 18F-FDG PET/MRI will stay overnight & will be imaged with 18F-FDG in the morning on day 2 under fasting conditions
干预措施: PET/MRI (Device)
68Ga-Galmydar + PET Imaging
Lymphoma patients: baseline prior to the start of chemotherapy treatment, after the patient has had at least 250 mg/m^2 of anthracycline (after the 5th cycle & before the 6th cycle of anthracycline in Non-Hodgkin lymphoma or after the 5th cycle (10 treatments) in Hodgkin lymphoma, 1-3 weeks after the 5th cycle of anthracycline), and 12-months (+/- 1 month) post-treatment
Breast patients: baseline prior to the start of all chemotherapy treatments, baseline after Paclitaxel and prior to the start of AC (Adriamycin & Cyclophosphamide) for patients treated with the Keynote-522 regimen, 1-2 weeks after the last dose (4 cycles) of AC, and 12-months (+/- 1 month) post-treatment
Echocardiography will be performed at all PET imaging sessions & at 6- and 9-months post-chemotherapy
A subset of 3 breast & 3 lymphoma patients will undergo 18F-FDG PET/MRI. Patients undergoing 18F-FDG PET/MRI will stay overnight & will be imaged with 18F-FDG in the morning on day 2 under fasting conditions
干预措施: 68Ga-Galmydar (Drug)
68Ga-Galmydar + PET Imaging
Lymphoma patients: baseline prior to the start of chemotherapy treatment, after the patient has had at least 250 mg/m^2 of anthracycline (after the 5th cycle & before the 6th cycle of anthracycline in Non-Hodgkin lymphoma or after the 5th cycle (10 treatments) in Hodgkin lymphoma, 1-3 weeks after the 5th cycle of anthracycline), and 12-months (+/- 1 month) post-treatment
Breast patients: baseline prior to the start of all chemotherapy treatments, baseline after Paclitaxel and prior to the start of AC (Adriamycin & Cyclophosphamide) for patients treated with the Keynote-522 regimen, 1-2 weeks after the last dose (4 cycles) of AC, and 12-months (+/- 1 month) post-treatment
Echocardiography will be performed at all PET imaging sessions & at 6- and 9-months post-chemotherapy
A subset of 3 breast & 3 lymphoma patients will undergo 18F-FDG PET/MRI. Patients undergoing 18F-FDG PET/MRI will stay overnight & will be imaged with 18F-FDG in the morning on day 2 under fasting conditions
干预措施: 18F-FDG (Drug)
结局指标
主要结局
Changes in 68Ga-Galmydar Standardized Uptake Value (SUV) in patients with and without cardiotoxicity
时间窗: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
The ability of 68Ga-Galmydar PET/MRI to detect chemotherapy-induced cardiotoxicity will be determined by measuring changes in PET signal (SUV) over time in patients with and without cardiotoxicity. Classification of whether or not a patient develops cardiotoxicity will be determined by evaluation of the left ventricular ejection fraction (LVEF) on echocardiography. Cardiac SUVmean values between pre- and post-chemotherapy will be obtained from PET scans. SUV quantifies the percent of radiotracer that accumulates in a region compared with if the tracer was distributed throughout the body. Mixed effects regression (MER) will be used to examine decreased uptake in those with cardiotoxicity compared to those without toxicity. The regression coefficient for time-by-group interaction will describe the different time trend of SUV uptake over time between two groups.
Correlation between 68Ga-Galmydar PET signal and the 18F-FDG PET signal
时间窗: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
The relationship between 68Ga-Galmydar PET signal to 18F-FDG PET signal will be indicated using a Pearson or Spearman coefficient, whichever is appropriate. Spearman's correlation coefficient evaluates the association and the association's direction between two ranked continuous variables. Spearman's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship. Pearson's correlation coefficient is a measure that evaluates the association between two continuous variables with the assumption that the variables have a linear relationship. Pearson's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.
Correlation of PET signal and Left Ventricular Ejection Fraction (LVEF) from echocardiography
时间窗: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
Echocardiography will be conducted prior to starting chemotherapy, at each of the PET/MR visits, and at 6 and 9-months post-chemotherapy for left ventricular function assessment. LVEF is the percentage of blood in the heart's left ventricle that ejects with each contraction. LVEF is calculated by the following equation: LVEF = (End Diastolic Volume (EDV) - End Systolic Volume (ESV)) / EDV × 100 The relationship between LVEF changes and LV-SUV will be assessed similarly with a Pearson correlation.
Correlation of PET signal and Left Ventricular Ejection Fraction (LVEF) from MR
时间窗: From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks)
MR will be performed with each PET imaging scan. LVEF is the percentage of blood in the heart's left ventricle that ejects with each contraction. LVEF is calculated by the following equation: LVEF = (End Diastolic Volume (EDV) - End Systolic Volume (ESV)) / EDV × 100 The relationship between LVEF changes and LV-SUV will be assessed similarly with a Pearson correlation.
次要结局
- Sensitivity of 68Ga-Galmydar(From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks))
- Specificity of 68Ga-Galmydar(From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks))
- Comparison of segmental 68Ga-Galmydar PET SUV to native T1 values from MR(From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks))
- Comparison of global 68Ga-Galmydar PET SUV to native T1 values from MR(From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks))
- Comparison of segmental 68Ga-Galmydar PET SUV to native T2 values from MR(From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks))
- Comparison of global 68Ga-Galmydar PET SUV to native T2 values from MR(From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks))
- Comparison of global 68Ga-Galmydar PET SUV to global longitudinal strain from MR(From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks))
- Comparison of global 68Ga-Galmydar PET SUV to global circumferential strain from MR(From baseline imaging through 12 months post treatment imaging (total estimated time 57-58 weeks))