Ovarian CancerMicroFluONCT05633836
MicroFluO: FLUorescence-guided Surgery for Ovarian Cancer
A study testing Fluorescence guided surgery in people with Ovarian Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Fluorescence guided surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2024to 9 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Borderline ovarian tumor.
- Non French speaking patient.
- Patient under a legal protection measure (guardianship, curatorship, safeguard of justice).
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Hôpital européen Georges-Pompidou
Paris, Île-de-France Region, 75015
About this study
Official title: Indocyanine Green FLUorescence-guided Surgery to Achieve MICROscopic Cytoreduction After Macroscopically Complete Cytoreductive Surgery in Patients With Epithelial Ovarian Cancer
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.
Read more
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.
- Conditions
- Ovarian Cancer
- Being tested
- Fluorescence guided surgery
- Keywords
- ovarian cancer, fluorescence guided surgery, indocyanine green, cytoreductive surgery, peritoneal carcinomatosis
- Medical subject headings
- Ovarian Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence guided surgeryProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence guided surgery | Experimental | 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 Receives: Procedure: Fluorescence guided surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of microscopic metastases detected by fluorescence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start4 Mar 2024
- Primary completion9 Aug 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Site de Recherche Intégrée sur le Cancer - CAncer Research for PErsonalized Medicine (SIRIC-CARPEM), France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633836
- Sponsor's protocol ID
- APHP220637
- Other IDs
- 2022-A00522-41
- Acronym
- MicroFluO
- Status last verified
- Jan 2025
- First submitted
- 21 Nov 2022
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green FLUorescence-guided Surgery to Achieve MICROscopic Cytoreduction After Macroscopically Complete Cytoreductive Surgery in Patients With Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05633836
- Acronym / sponsor ID
- MicroFluO / APHP220637
- Conditions
- Ovarian Cancer
- Keywords
- ovarian cancer, fluorescence guided surgery, indocyanine green, cytoreductive surgery, peritoneal carcinomatosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Site de Recherche Intégrée sur le Cancer - CAncer Research for PErsonalized Medicine (SIRIC-CARPEM), France
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescence guided surgery | Experimental | Procedure: Fluorescence guided surgeryDuring 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Borderline ovarian tumor.
- Non French speaking patient.
- Patient under a legal protection measure (guardianship, curatorship, safeguard of justice).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescence guided surgeryDuring 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 | Procedure or surgery | Fluorescence guided surgery |
Primary outcome
Rate of microscopic metastases detected by fluorescence
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescence guided surgery in people with Ovarian Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of microscopic metastases detected by fluorescence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.