Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging (IMOVA)

Institut Bergonié

Status: Completed

Conditions: Ovarian Cancer

Treatments: Device: Functional Imaging previous the second course; Device: Functional Imaging previous the surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02792959

IB 2013-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Functional imaging

Experimental group

Description:

A pilot study to evaluate the response to neoadjuvant chemotherapy for advanced ovarian cancer by multimodal functional imaging (Fusion MRI and FDG-PET-CT)

Treatment:

Device: Functional Imaging previous the second course

Device: Functional Imaging previous the surgery