Diagnostic Performance of PET/MRI Versus Standard of Care Imaging (PET/CT and/or CT and/or PET) in Preoperative Women With Presumed Early-stage High Grade Endometrial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percentage of patients without any metastatic lesion noted on PET/MRI that do not have malignancy noted on surgical pathology
研究概览
简要总结
This study is investigating if positron emission tomography (PET)/Magnetic resonance imaging (MRI) is more effective than the currently used imaging modalities (computed tomography [CT], or PET/CT) for high-risk endometrial cancer.
The name of the intervention involved in this study is:
Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI)
详细描述
This research study involves undergoing a diagnostic imaging procedure called positron emission tomography/magnetic resonance imaging (PET/MRI). This type of scan uses a powerful magnet and a special drug that emits a small but detectable amount of radiation to show detailed images of tumors. This study, will examine the diagnostic effectiveness of positron emission tomography/magnetic resonance imaging (PET/MRI), which will be the intervention. The study will compare the results of this scan to either the computed tomography (CT) or PET/CT that participants would normally undergo as a standard of care for high-risk endometrial cancer.
The research study procedures include a screening for eligibility and a single study visit.
- Participants will undergo the PET/MRI in one study visit of approximately four hours.
- It is expected that about thirty-three (33) people will take part in this research study.
The U.S. Food and Drug Administration (FDA) has approved the PET/MRI scanner as a diagnostic modality option for indications that include for high-risk endometrial cancer.
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-85 years old with an endometrial biopsy-confirmed diagnosis of either grade 3 endometrioid, serous, carcinosarcoma, undifferentiated or mixed cell carcinoma
- •Must have presumed stage I disease, i.e., no symptoms suggesting disease outside of the uterus (weight loss, early satiety, bloating, changes in bowel movement, etc.)
- •Planning to undergo cytoreductive surgery with a Gynecologic oncologist employed by Massachusetts General Hospital
- •No previous history of chronic severe renal insufficiency and a glomerular filtration rate of >30 mL/min/1.73m
- •If the patient has a history of acute renal failure but their GFR as recovered to above 30,
排除标准
- •Weight greater than 300lbs (the PET/MRI table weight limit) or BMI > 33
- •Subjects less than 18 years of age or greater than 85 years of age
- •Has Electrical implants, such as cardiac pacemakers or perfusion pumps
- •Has Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, prosthetic heart valves that are not compatible with the gradient maps of our scanners, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants not compatible with a 3 Tesla MR.
- •Is actively anticipating being pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required on the day of the scan before the subject can participate)
- •Suffers from claustrophobia
- •If research-related radiation exposure exceeds current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months)
- •Is unable to lie comfortably on a bed inside the PET/MRI bore as assessed by physical examination and medical history (e.g., back pain, arthritis)
- •Subject is under the direct professional supervision of the principal investigator
- •A history of chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
- •Perioperative liver transplantation period
结局指标
主要结局
Percentage of patients without any metastatic lesion noted on PET/MRI that do not have malignancy noted on surgical pathology
时间窗: Baseline
Specificity of PET/MRI to detect abscence of metastatic lesions
Percentage of patients with a metastatic lesion noted on PET/MRI that have a true malignancy noted on surgical pathology of that lesion
时间窗: Baseline
Sensitivity of PET/MRI to detect metastatic lesions
次要结局
未报告次要终点
研究者
Onofrio A. Catalano, MD, PhD
Principal Investigator
Massachusetts General Hospital