IMPROCAS - Improved Prediction of Ovarian Cancer Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- - to evaluate the diagnostic performance of DCE MRI, DKI and 31P MRS
研究概览
简要总结
The aim of this project is to investigate nuclear magnetic resonance (NMR)-derived metabolomics from blood samples, functional and metabolic MRI techniques and their ability to improve ovarian cancer diagnostics. Based on the above, a model able to identify ovarian cancer and improve the accuracy of correct diagnosis and disease severity will be proposed.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Suspected epithelial ovarian cancer (and referred to dept. of Gynaecology and Obstetrics, AUH)
- •Understanding Danish
- •Age 18 – 85 years
排除标准
- •Contraindications for MRI with contrast: - eGFR less than 30 ml/min/1.73m2 - Severe unstable asthma - Pacemaker, implantable cardiac defibrillator, neurostimulator or cochlear implant - Metal foreign bodies such as fragments and irremovable piercings - Unsafe medical implants (safety of heart valves, hips and the like must be confirmed) - Claustrophobia - Largest circumference including arms > 160 cm
- •Substantial cognitive disability that would influence the patients’ ability to either give truly informed consent or listen to / comply with safety-related instructions.
- •Severe renovascular disease
- •Any other malign disease or recidiv of a former malign disease present within the last 3-5 years (except benign basal basocelluar carcinoma (BBC))
- •Allergy to pyruvate
结局指标
主要结局
- to evaluate the diagnostic performance of DCE MRI, DKI and 31P MRS
- to evaluate the diagnostic performance of DCE MRI, DKI and 31P MRS
- to create a diagnostic algorithm that can help the clinician to classify correct diagnosis and FIGO-staging of ovarian cancer.
- to create a diagnostic algorithm that can help the clinician to classify correct diagnosis and FIGO-staging of ovarian cancer.
- to assess if the HP 13C MRI contributes to correct histopathological diagnosis.
- to assess if the HP 13C MRI contributes to correct histopathological diagnosis.
- to assess if the HP 13C MRI contributes to staging of ovarian cancer.
- to assess if the HP 13C MRI contributes to staging of ovarian cancer.
- For the NMR-derived analyses from the blood samples: the ability to distinguish patients with cancer from those without cancer.
- For the NMR-derived analyses from the blood samples: the ability to distinguish patients with cancer from those without cancer.
For the NMR-derived analyses from the blood samples: the prediction of correct histopathological diagnosis
For the NMR-derived analyses from the blood samples: the prediction of correct histopathological diagnosis
次要结局
- - To assess the repeatability and reproducibility of multiparametric pelvic MRI in patients suspected with ovarian cancer
- For the NMR-derived analyses from the blood samples: - the prediction of surgical resectability
研究者
Malene Aastrup
Scientific
Aarhus University