Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging (Fusion MRI and FDG-PET-CT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
研究概览
简要总结
This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent.
详细描述
This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent. It is a single center evaluation of the study treatment.
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
- •Epithelial ovarian carcinoma, fallopian tube, or primary peritoneal carcinoma FIGO IIIC-IV histologically confirmed by biopsy and documented stage and untreated
- •Pre-treatment abdominopelvic PET-CT and MRI within 4 weeks before neoadjuvant chemotherapy.
- •During laparoscopy performed by an experienced surgeon in the treatment of ovarian cancer, patient considered ineligible for tumor cell kill at the outset.
- •A life expectancy of greater than three months
- •An eligible patient for Paclitaxel and Carboplatine based chemotherapy.
- •Membership of a social security scheme
- •Patient information and signed, dated written informed consent
排除标准
- •Pre-treated using chemotherapy, radiology, or surgery for an ovarian cancer.
- •Contraindication to MRI with the injection of contrast product, i.e, the first three months pregnancy, claustrophobia, major allergic antecedents, pacemaker, some surgery clips, some heart valves, cava filter, implanter pumps, cochlear implants, metallic extraneous malter.
- •Uncontrolled diabetes
- •Pregnancy and nursing
- •Other uncontrolled medical conditions as thyroid pathology, neuropsychiatric disease, infection, coronary insufficiency or grade 3 - 4 heart disease established by association "New York Heart"
- •Patient deprived of liberty and legally protect adult, or not in position to give consent.
结局指标
主要结局
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
时间窗: After four cycles of chemotherapy, 12 weeks
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
时间窗: After four cycles of chemotherapy, 12 weeks
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET) . The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
时间窗: After four cycles of chemoterapy, 12 weeks
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (MTV). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
时间窗: After one cycle of chemotherapy, 3 weeks
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography (PET) will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
时间窗: After four cycle of chemoterapy, 12 weeks
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
时间窗: After four cycles of chemotherapy, 12 weeks
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
时间窗: After four cycles of chemotherapy, 12 weeks
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter of ADC functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location
时间窗: After four cycles of chemotherapy, 12 weeks
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability between observers of quantization parameter MTV of functional imaging Positron Emission Tomography (PET). The functional imaging Positron Emission Tomography will be interpreted independently by 2 radiologists and 2 nuclear medicine specialists, in blind to results found by the other.
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
时间窗: After four cycles of chemotherapy, 12 weeks
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of functional imaging Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
时间窗: After four cycles of chemoterapy, 12 weeks
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
时间窗: After one cycle of chemoterapy, 3 weeks
Individual Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUV max of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
时间窗: After one cycle of chemotherapy, 3 weeks
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
时间窗: After four cycles of chemoterapy, 12 weeks
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter SUVmax of functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
时间窗: After four cycles of chemotherapy, 12 weeks
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observers of quantization parameter ADC of Magnetic Resonance Imaging (MRI). The Magnetic Resonance Imaging will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
时间窗: After four cycles of chemotherapy, 12 weeks
Average Intra-class Correlation Coefficients (Absolute agreement) are presented by location to evaluate the reliability within observer of quantization parameter MTV functional imaging positron emission tomography (PET). The functional imaging positron emission tomography will be interpreted independently twice by the same radiologist and nuclear medicine specialist.
次要结局
- Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1(After four cycles of chemotherapy, 12 weeks)
- Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1(After one cycle of chemotherapy, 3 weeks)
- Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1(After four cycles of chemotherapy, 12 weeks)
- Overall Survival(10 months)
- Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pretherapeutic and After One Cycle of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)(After one cycle of chemotherapy, 3 weeks)
- Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125(After one and four cycle(s) of chemotherapy (after 3 and 12 weeks))
- Progression-free Survival as Per RECIST v1.1(9, 13, 14 months)
- Complete Surgery Resection(Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery)
- Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1(After four cycles of chemotherapy, 12 weeks)
- Spearman Correlation Coefficient Between Marker CA125 and the Relative Variations (Between Pre-therapeutic and After Four Cycles of Chemotherapy) of the PET Parameters (SUVmax, MTV, SUVN, SUL and TLG)(After four cycles of chemotherapy, 12 weeks)
- Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1(After four cycles of chemotherapy, 12 weeks)
- Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1(After one cycle of chemotherapy, 3 weeks)
- Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1(After four cycles of chemotherapy, 12 weeks)
- Peritoneal Extent Assessed by Fagotti Score Using MRI Data(Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery)