Clinical trial NCT02792959: Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging
Official title: Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging (Fusion MRI and FDG-PET-CT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
name: Ligue contre le cancer, France
First posted: 2016-06-08
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
timeFrame: Pre-therapeutic
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
timeFrame: Pre-therapeutic
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
timeFrame: Pre-therapeutic
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
timeFrame: Pre-therapeutic
measure: Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
timeFrame: Pretherapeutic
measure: Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
timeFrame: Pretherapeutic
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After one cycle of chemoterapy, 3 weeks
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After four cycles of chemoterapy, 12 weeks
measure: Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
timeFrame: Pre-therapeutic
measure: Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
timeFrame: Pre-therapeutic
measure: Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
timeFrame: Pre-therapeutic
measure: Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
timeFrame: Pre-therapeutic
measure: Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
timeFrame: Pretherapeutic
measure: Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
timeFrame: Pretherapeutic
measure: Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After one cycle of chemoterapy, 3 weeks
measure: Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
timeFrame: After once cycle of chemoterapy, 3 weeks
measure: Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After one cycle of chemoterapy, 3 weeks
measure: Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
timeFrame: After once cycle of chemotherapy, 3 weeks
measure: Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After four cycles of chemoterapy, 12 weeks
measure: Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location
timeFrame: After four cycles of chemoterapy, 12 weeks
measure: Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After four cycle of chemoterapy, 12 weeks
measure: Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location
timeFrame: After four cycles of chemotherapy, 12 weeks
Secondary outcomes:
measure: 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)
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: 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)
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125
timeFrame: After one and four cycle(s) of chemotherapy (after 3 and 12 weeks)
measure: Complete Surgery Resection
timeFrame: Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery
measure: Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1
timeFrame: After one cycle of chemotherapy, 3 weeks
measure: Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1
timeFrame: After four cycles of chemotherapy, 12 weeks
measure: Peritoneal Extent Assessed by Fagotti Score Using MRI Data
timeFrame: Pre-therapeutic
measure: Peritoneal Extent Assessed by Fagotti Score Using MRI Data
timeFrame: Interval surgery visit: up to 3 weeks after cycle 4 of chemotherapy and until the day before the surgery
measure: Overall Survival
timeFrame: 10 months
measure: Progression-free Survival as Per RECIST v1.1
timeFrame: 9, 13, 14 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
state: Gironde
Study officials:
affiliation: Institut Bergonié
name: Anne-Laure CAZEAU, MD
role: STUDY_CHAIR
References: