N/A
N=11
Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02792959 ↗Enrolled (actual)
11
Serious AEs
27.3%
Results posted
Apr 2021
Primary outcome: Primary: Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location — 0.992; 0.997; 0.983; 0.997 proportion of agreement
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Functional Imaging previous the second course (Device); Functional Imaging previous the surgery (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Institut Bergonié
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
0.923; 0.953; 0.962; 0.942 | — |
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
0.960; 0.976; 0.981; 0.970 | — |
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
0.957; 0.248; 0.998; 0.943 | — |
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location |
0.670; 0.937; 0.347; 0.823; 0.654; 0.997 | — |
| PRIMARY Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
0.961; 0.730; 0.862; 0.543; 0.834; 1.000 | — |
| PRIMARY Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
0.980; 0.844; 0.926; 0.703; 0.910; 1.000 | — |
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
0.923; 0.953; 0.962; 0.942 | — |
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
0.960; 0.976; 0.981; 0.970 | — |
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
0.957; 0.248; 0.998; 0.943 | — |
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location |
0.670; 0.937; 0.347; 0.823; 0.654; 0.997 | — |
| PRIMARY Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
0.961; 0.730; 0.862; 0.543; 0.834; 1.000 | — |
| PRIMARY Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
0.980; 0.844; 0.926; 0.703; 0.910; 1.000 | — |
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
0.923; 0.953; 0.962; 0.942 | — |
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
0.960; 0.976; 0.981; 0.970 | — |
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
0.957; 0.248; 0.998; 0.943 | — |
| PRIMARY Inter-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - AverageIntra-class Correlation Coefficients by Location |
0.978; 0.398; 0.999; 0.971 | — |
| PRIMARY Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
0.961; 0.730; 0.862; 0.543; 0.834; 1.000 | — |
| PRIMARY Inter-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
0.980; 0.844; 0.926; 0.703; 0.910; 1.000 | — |
| PRIMARY Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
0.893; 0.998; 0.993; 0.997; 0.317; 1.000 | — |
| PRIMARY Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
1.000; 1.000; 0.944; 1.000 | — |
| PRIMARY Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
0.794; 0.794; 0.975; 0.987 | — |
| PRIMARY Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location |
0.885; 0.885; 0.987; 0.993 | — |
| PRIMARY Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
0.930; 0.654; 0.767; 0.088; 0.686; 0.804 | — |
| PRIMARY Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
0.755; 0.760; -0.091; 0.622; 0.884; 0.998 | — |
| PRIMARY Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
0.893; 0.998; 0.993; 0.997; 0.317; 1.000 | — |
| PRIMARY Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
1.000; 1.000; 0.944; 1.000 | — |
| PRIMARY Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
0.794; 0.794; 0.975; 0.987 | — |
| PRIMARY Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location |
0.885; 0.885; 0.987; 0.993 | — |
| PRIMARY Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
0.930; 0.654; 0.767; 0.088; 0.686; 0.804 | — |
| PRIMARY Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
0.755; 0.760; -0.091; 0.622; 0.884; 0.998 | — |
| PRIMARY Individual Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Individual Intra-class Correlation Coefficients by Location |
1.000; 1.000; 1.000; 0.971; 1.000 | — |
| PRIMARY Intra-rater Reliability of Positron Emission Tomography (PET) Maximum Standardized Uptake Value (SUVmax) - Average Intra-class Correlation Coefficients by Location |
1.000; 1.000; 0.944; 1.000 | — |
| PRIMARY Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Individual Intra-class Correlation Coefficients by Location |
0.794; 0.794; 0.975; 0.987 | — |
| PRIMARY Intra-rater Reliability of Positron Emission Tomography (PET) Metabolic Tumoral Volume (MTV) - Average Intra-class Correlation Coefficients by Location |
0.885; 0.885; 0.987; 0.993 | — |
| PRIMARY Intra-rater Reliability of Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Individual Intra-class Correlation Coefficients by Location |
0.930; 0.654; 0.767; 0.088; 0.686; 0.804 | — |
| PRIMARY Intra-rater Reliability of PET Magnetic Resonance Imaging (MRI) Apparent Diffusion Coefficient (ADC) - Average Intra-class Correlation Coefficients by Location |
0.964; 0.791; 0.868; 0.162; 0.814; 0.891 | — |
| SECONDARY 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) |
-0.091; -0.030; -0.212; -0.212; -0.164 | — |
| SECONDARY 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) |
0.811; 0.775; 0.811; 0.811; 0.775 | — |
| SECONDARY Spearman Correlation Test Between the Relative Variation of Apparent Diffusion Coefficient (ADC) and Marker CA125 |
0.103; -0.571 | — |
| SECONDARY Complete Surgery Resection |
10; 0 | — |
| SECONDARY Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1 |
-67.3; -11.3 | 0.067 |
| SECONDARY Descriptive Statistics of Relative Variations of PET Parameter SUVmax by Response as Per RECIST V1.1 |
-67.3; -11.3 | 0.067 |
| SECONDARY Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1 |
-38.5; -3.3 | 0.296 |
| SECONDARY Descriptive Statistics of Relative Variations of PET Parameter MTV by Response as Per RECIST V1.1 |
-38.5; -3.3 | 0.296 |
| SECONDARY Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1 |
-65.2; -16.2 | 0.067 |
| SECONDARY Descriptive Statistics of Relative Variations of PET Parameter SUVN by Response as Per RECIST V1.1 |
-65.2; -16.2 | 0.067 |
| SECONDARY Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1 |
-97.7; -7.5 | 0.036 sig |
| SECONDARY Descriptive Statistics of Relative Variations of PET Parameter TLG by Response as Per RECIST V1.1 |
-97.7; -7.5 | 0.036 sig |
| SECONDARY Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1 |
-66.9; -14.7 | 0.036 sig |
| SECONDARY Descriptive Statistics of Relative Variations of PET Parameter SUL by Response as Per RECIST V1.1 |
-66.9; -14.7 | 0.036 sig |
| SECONDARY Descriptive Statistics of Relative Variations of MRI Parameter ADC by Response as Per RECIST V1.1 |
9.3; 4.3 | 0.602 |
| SECONDARY Descriptive Statistics of Relative Variations of MRI Parameters ADC by Response as Per RECIST V1.1 |
38.6; -18.0 | 0.192 |
| SECONDARY Peritoneal Extent Assessed by Fagotti Score Using MRI Data |
1; 1; 2; 2; 3; 1 | — |
| SECONDARY Peritoneal Extent Assessed by Fagotti Score Using MRI Data |
1; 1; 2; 2; 3; 1 | — |
| SECONDARY Overall Survival |
90 | — |
| SECONDARY Progression-free Survival as Per RECIST v1.1 |
90.0; 78.8; 67.5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02792959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.