MicroFluO: FLUorescence-guided Surgery for Ovarian Cancer (MicroFluO)
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| ClinicalTrials.gov Identifier: NCT05633836 |
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Recruitment Status :
Not yet recruiting
First Posted : December 1, 2022
Last Update Posted : December 1, 2022
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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 |
| 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 |
|---|---|
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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
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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 |
- Rate of microscopic metastases detected by fluorescence [ Time Frame: 12 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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).
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
| Contact: Breno Melo | 33140271840 | gestion-locale.drc@aphp.fr | |
| Contact: Natacha Nohilé | natacha.nohile@aphp.fr |
| France | |
| AP-HP, Hôpital européen Georges-Pompidou | |
| Paris, Ile-de-France, France, 75015 | |
| Contact: Henri Azaïs, MD henri.azais@aphp.fr | |
| 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). |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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ovarian cancer fluorescence guided surgery indocyanine green cytoreductive surgery peritoneal carcinomatosis |
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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 |