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Trial Title:
MicroFluO: FLUorescence-guided Surgery for Ovarian Cancer
NCT ID:
NCT05633836
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Conditions: Keywords:
ovarian cancer
fluorescence guided surgery
indocyanine green
cytoreductive surgery
peritoneal carcinomatosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Fluorescence guided surgery
Description:
During exploratory laparoscopy or at the end of macroscopically complete cytoreduction
surgery, indocyanine green fluorescence-guided surgery is performed to identify
peritoneal carcinoma lesions not visible in white light
Arm group label:
Fluorescence guided surgery
Summary:
Epithelial ovarian cancers (EOC) are discovered in 75% of cases at an advanced stage,
marked by the presence of peritoneal carcinomatosis. It has been shown that one of the
main prognostic factors is the achievement of a macroscopically complete cytoreductive
surgery, i.e. without visible peritoneal metastasis at the end of the procedure. The
prognosis of patients is inversely correlated to the tumor residue at the end of the
procedure, and 60% of patients present a peritoneal recurrence within two years after the
initial management. This suggests that microscopic peritoneal metastases may be present
that are not eradicated by surgery and not controlled by systemic chemotherapy. Their
presence could be involved in the mechanisms leading to the occurrence of peritoneal
recurrence.
The MicroPCI protocol (NCT03754569), showed that microscopic peritoneal metastases were
present at the end of macroscopically complete surgery of advanced-stage EOC in 98.14% of
cases.This naturally lead to the question of the impact of microscopic cytoreduction on
the prognosis of patients. Fluorescence detection of peritoneal metastases after
intravenous injection of indocyanine green (ICG) and their resection have already been
evaluated with promising results in digestive and ovarian carcinomas.
The objective of the MicroFluO protocol is to propose on the one hand a diagnostic time
by fluorescence during the laparoscopic evaluation performed to define the resectability
of the peritoneal carcinomatosis and also at the end of the macroscopically complete
cytoreductive surgery to perform the biopsy of the fluorescent areas suspected of
presenting residual microscopic peritoneal metastases.
Patients diagnosed with peritoneal carcinomatosis undergo exploratory laparoscopy, during
which lesion mapping is performed to assess the resectability of the lesions. A biopsy is
performed during this procedure to confirm the histological diagnosis. An initial
fluorescence mapping will be performed at this diagnostic time.
Once cytoreductive surgery has been performed, intravenous injection of ICG is performed
according to the manufacturer's recommendations. Peritoneal lesions emitting a
fluorescent signal will be sampled. These samples will be studied in anatomopathology
under the same conditions as the other surgical parts.
No increase in morbidity is expected in relation to this study. The number of specimens
taken is dependent on the peritoneal tumor burden.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient at least 18 years of age.
- Presenting with an epithelial ovarian cancer
- Affiliated to a social security system
- Having received full information on the organization of the research and having
given written consent.
Exclusion Criteria:
- Borderline ovarian tumor.
- Non French speaking patient.
- Patient under a legal protection measure (guardianship, curatorship, safeguard of
justice).
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AP-HP, Hôpital européen Georges-Pompidou
Address:
City:
Paris
Zip:
75015
Country:
France
Status:
Recruiting
Contact:
Last name:
Henri Azaïs, MD
Email:
henri.azais@aphp.fr
Start date:
May 2023
Completion date:
February 2024
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Collaborator:
Agency:
Site de Recherche Intégrée sur le Cancer - CAncer Research for PErsonalized Medicine (SIRIC-CARPEM), France
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05633836
