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MicroFluO: FLUorescence-guided Surgery for Ovarian Cancer (MicroFluO)

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ClinicalTrials.gov Identifier: NCT05633836
Recruitment Status : Not yet recruiting
First Posted : December 1, 2022
Last Update Posted : December 1, 2022
Sponsor:
Collaborator:
Site de Recherche Intégrée sur le Cancer - CAncer Research for PErsonalized Medicine (SIRIC-CARPEM), France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: Fluorescence guided surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Indocyanine Green FLUorescence-guided Surgery to Achieve MICROscopic Cytoreduction After Macroscopically Complete Cytoreductive Surgery in Patients With Epithelial Ovarian Cancer
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024


Arm Intervention/treatment
Experimental: Fluorescence guided surgery
During exploratory laparoscopy or at the end of macroscopically complete cytoreductive surgery, indocyanine green fluorescence-guided surgery is performed to identify peritoneal carcinoma lesions not visible in white light
Procedure: Fluorescence guided surgery
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




Primary Outcome Measures :
  1. Rate of microscopic metastases detected by fluorescence [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05633836


Contacts
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Contact: Breno Melo 33140271840 gestion-locale.drc@aphp.fr
Contact: Natacha Nohilé natacha.nohile@aphp.fr

Locations
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France
AP-HP, Hôpital européen Georges-Pompidou
Paris, Ile-de-France, France, 75015
Contact: Henri Azaïs, MD       henri.azais@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Site de Recherche Intégrée sur le Cancer - CAncer Research for PErsonalized Medicine (SIRIC-CARPEM), France
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05633836    
Other Study ID Numbers: APHP220637
2022-A00522-41 ( Registry Identifier: Agence nationale de sécurité du médicament et des produits de santé )
First Posted: December 1, 2022    Key Record Dates
Last Update Posted: December 1, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Two years after the last publication
Access Criteria:

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.

Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement.

Processing of shared data must comply with European General Data Protection Regulation (GDPR).


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
ovarian cancer
fluorescence guided surgery
indocyanine green
cytoreductive surgery
peritoneal carcinomatosis
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type