Integration of Radiomic Analysis Into the Multi-Modal Profiling of High-Grade Serous Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Comparison between radiologist tumor segmentation
研究概览
简要总结
The researchers are doing this study to find out whether the researchers can combine information provided by PET/MRI scans with information from tests on blood and tissue samples to develop a very detailed description (profile) of high-grade serous ovarian carcinoma (HGSOC), which could improve our ability to treat this disease.
The study researchers will use computers to analyze the combined results of the imaging tests and the genetic and immune system tests on the tumor samples. The study researchers think that this information will help them more accurately predict the way tumors respond to treatment, which may improve their ability to individualize treatments for this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •≥ 18 years of age or older
- •Histologically confirmed or clinically suspected FIGO stage IIIC-IV HGSOC
- •Signed consent to MSK Institutional tissue banking protocol IRB# 06-107 and signed or planned to sign IRB# 12-245, and planned to undergo multi-region tissue collection [under the above IRB protocols] and plan to undergo subsequent tissue analysis under biospecimen IRB# 15-
- •Staging standard-of-care contrast-enhanced CT of abdomen and pelvis (+/-chest) available in picture archiving and communication system (PACS) that was obtained at our institution as a part of standard-of-care work-up or submitted for from the outside
- •Plasma glucose ≤200 mg/dL
- •Negative pregnancy test, if a patient is of child-bearing potential
排除标准
- •Known allergy to gadolinium-based contrast medium requiring premedication or known adverse reactions to gadolinium-based contrast medium.
- •Known history of impaired renal function, with documented eGFR <30 within 30 days prior to PET/MRI.
- •Patients who cannot give valid informed consent because of general medical or physical condition, or physiologic status unrelated to presence of ovarian cancer
- •Patients who are unwilling or unable to undergo PET/MRI including patients with absolute or relative contraindications to MRI including breast tissue expanders, cardiac pacemakers and defibrillators, non MRI-compatible aneurysm clips, neurostimulators, programmable CSF shunts, vascular stents, claustrophobia, or inability to lie flat for the duration of the examination.
- •Patients with metallic hardware, implant, or device in the abdomen or pelvis that might distort the local magnetic field and compromise image quality.
- •Radiotherapy to the abdomen or pelvis within 12 months of the screening visit.
- •Subjects with a current diagnosis of ovarian cancer other than HGSOC
- •Patients with known synchronous primary endometrial cancer or past history of endometrial cancer.
- •Patients who have received prior chemotherapy for any abdominal or pelvic tumor. Patients may have received prior adjuvant chemotherapy for breast cancer.
- •With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with excluded known concurrent malignancy.
- •Unresolved bowel obstruction.
- •History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study or interfere with patient's participation for the full duration of the study.
- •Absence of any target lesions ( ≥1-2 cm) in the pelvis (right adnexa, left adnexa, infra-colic omentum, pelvic peritoneum) visible on staging standard-of-care CE-CT and accessible for tissue sampling at laparoscopy and/or primary/ interval debulking surgery.
研究组 & 干预措施
Imaged prior to primary debulking surgery
Imaging will include research PET/MRI of pelvis within 30 days of multiregion tissue collection. Concretely, in patients triaged to primary debulking surgery (PDS), PET/MRI will be obtained within 30 days preceding multi-region tissue collection at the time of PDS (already being done under IRB# 06-107).
干预措施: PET/MRI (Diagnostic Test)
Imaged prior to primary debulking surgery
Imaging will include research PET/MRI of pelvis within 30 days of multiregion tissue collection. Concretely, in patients triaged to primary debulking surgery (PDS), PET/MRI will be obtained within 30 days preceding multi-region tissue collection at the time of PDS (already being done under IRB# 06-107).
干预措施: Contrast enhanced CT (Diagnostic Test)
Imaged pre/postneoadjuvant chemotherapy (NACT)
In patients triaged to neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS), PET/MRI will be obtained at two time points, i.e. first within 30 days preceding NACT/ multi-region laparoscopic tissue sampling (already being done under IRB# 06-107) and, second, any time after completion of NACT and before multi-region tissue collection at the time of interval debulking surgery (already being done under IRB# 06-107).
干预措施: PET/MRI (Diagnostic Test)
Imaged pre/postneoadjuvant chemotherapy (NACT)
In patients triaged to neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS), PET/MRI will be obtained at two time points, i.e. first within 30 days preceding NACT/ multi-region laparoscopic tissue sampling (already being done under IRB# 06-107) and, second, any time after completion of NACT and before multi-region tissue collection at the time of interval debulking surgery (already being done under IRB# 06-107).
干预措施: Contrast enhanced CT (Diagnostic Test)
结局指标
主要结局
Comparison between radiologist tumor segmentation
时间窗: 1 year
Radiologist-defined tumor volumes will be used to train and validate a machine learning algorithm for generating segmentations. The data will be split into 70%-30% of training and test sets, respectively. The comparisons will be performed on a slice-by-slice and lesion-bylesion basis, which should ensure sufficient numbers of examples for testing.
次要结局
未报告次要终点