NCT02144311已完成不适用
Benchmarking Intra-tumor Heterogeneity In Ovarian Cancer: Linking In-vivo Imaging Phenotypes With Histology And Genomics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Genomic markers of spatial heterogeneity
研究概览
简要总结
The purpose of this research study is to learn if differences seen in scans before surgery match differences seen when looking at tumor samples with pathology and genetic tests. In this study we will use Magnetic Resonance Imaging [MRI] and Positron Emission Tomography [PET] scans. No direct clinical benefits will come from the results of this 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age on the day of signing the informed consent.
- •Histologically confirmed or suspected stage III or IV high-grade serous ovarian cancer.
- •Scheduled to undergo primary debulking surgery.
排除标准
- •Pregnant patients
- •Patients who because of general medical or psychiatric condition, or physiologic status unrelated to the presence of ovarian cancer cannot give valid informed consent
- •Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
- •Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI/
- •Radiotherapy to the abdomen or pelvis within 6 months of the screening visit. Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible
- •Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met:
- •Stage not greater than IB
- •No more than superficial myometrial invasion
- •No vascular or lymphatic invasion
- •No poorly differentiated subtypes, including serous, clear cell, or other FIGO Grade 3 lesions.
- •Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients who have received neoadjuvant chemotherapy prior to their initial debulking are excluded. 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 other invasive malignancies who had (or have) any evidence of the other cancer present within the last 3 years are excluded.
- •Unresolved bowel obstruction.
- •History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with patient's participation for the full duration of the study.
- •Absence of target lesions (> 2.0 cm) on staging CT
- •Patients unlikely to be optimally debulked at surgery (tumor implants in difficult to reach places [i.e. falciform ligament or porta hepatis], suprarenal retroperitoneal lymphadenopathy)
结局指标
主要结局
Genomic markers of spatial heterogeneity
时间窗: 1 year
by evaluating spatially explicit phenotypic clusters based on a combination of perfusion, diffusion and metabolic tumor profiles (maps) in both ovarian tumors and metastatic peritoneal/omental implants of patients with HGSOC undergoing primary debulking surgery (PDS).
次要结局
- Histological and immunohistochemical features(1 year)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Ovarian Tumor Biopsies to Study Response to TreatmentsEpithelial Ovarian CancerNCT02952521University Health Network, Toronto5
招募中
不适用
A Prospective Multicenter Diagnostic Biomarker Study to Discriminate Borderline From Stage I Invasive Ovarian CancerStage I Ovarian CancerBorderline Ovarian TumorsNCT06709872KU Leuven400
已完成
不适用
Comparison Between Two Different Tissue-Level Implant Systems: A Prospective Clinical StudyPeri-implant Bone LossImplant StabilityVertical Soft Tissue ThicknessNCT04761445Saint-Joseph University8
已完成
不适用
Comparison Between Results of 2 Laparoscopic Surgical Procedures in Operable Colon Cancer Cases in Upper EgyptColon Cancer Stage IColon Cancer Stage IINCT05421702Sohag University150
招募中
不适用
Unravelling Tumour Biology In Ovarian Cancer With Precision ImagingHigh Grade Serous Ovarian CancerNCT06084195Institut du Cancer de Montpellier - Val d'Aurelle120