Cervix CancerNCT02221076
Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Procedures.
A study testing Confocal Laser Endomicroscopy (CLE) in people with Cervix Cancer and Endometrium Cancer, run by Mauna Kea Technologies at 1 site in France.
Trial summary
The protocol aims at demonstrating the technical feasibility and safety of doing endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy, nCLE) during colposcopy, hysteroscopy, and surgical procedures (open surgery and laparoscopic robot assisted or… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Cancer, Endometrium Cancer, Ovarian Cancer
- What is being tested?
- Confocal Laser Endomicroscopy (CLE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to 18 Apr 2016
- 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
- Patients scheduled for a colposcopy
- Patients scheduled for a hysteroscopy
- Patients scheduled for a surgical treatment for a suspected cervix/ endocervix/ endometrium lesion
- 18 years or older.
Who cannot join
- Allergy to fluorescein
- Previous life-threatening allergic reactions and known hypersensitivity
- Pregnancy or breast-feeding
- History of cardio-pulmonary disease (including bronchial asthma)
- Restricted renal function
- Patients under a beta-blockers treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Examinations or Surgical Procedures for Gynecological Cancers : a Feasibility Study
The protocol aims at demonstrating the technical feasibility and safety of doing endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy, nCLE) during colposcopy, hysteroscopy, and surgical procedures (open surgery and laparoscopic robot assisted or not) to examine all pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.
Read the detailed description
This is a prospective study: about 75 patients (25 for each pathology) scheduled for a colposcopy or hysteroscopy examination or for a surgical treatment of the cervix/endocervix/endometrium/ovarian or tubal cancer will be enrolled. They will undergo the diagnostic consultation or surgical procedure, as per standard of care, plus an additional pCLE/nCLE procedure with the prototype probes, which will add between 5 and 10 minutes maximum to the examination.
The confocal miniprobe will be positioned against the surface of these organs or inside these same organs if the tumor is intratissular through a needle, and sequences will be acquired. Final diagnosis will be obtained for the patient, either through the result of the biopsies or through surgical pathology if the patient's lesion is surgically resected. Then imaging will be performed as well ex vivo on the resected specimens to provide additional stable imaging, and compare image quality to in vivo imaging.
The clinical endpoints of the study are:
- One or several Confocal Miniprobe designs optimized for use during colposcopy and hysteroscopy
- An optimized protocol of operations when using the designed Confocal Miniprobes during colposcopy and hysteroscopy as well as in the surgical setting, robotized or not (staining, use of accessories to hold the probes, etc...)
- A first atlas of endomicroscopic images obtained in the cervix, endocervix and endometrium
- The number, type and severity of recorded adverse events (to evaluate the safety).
Final objectives of CLE in gynecology:
- During colposcopic examination of the exocervix and conization, CLE is intended to be used to target biopsy and guide resection.
- During hysteroscopic examination of the endocervix, CLE is intended to be used to target biopsy and guide resection. Its ability to diagnose endocervical cancer will be evaluated.
- For endometrium cancer, CLE is to be used to target biopsy during hysteroscopy procedures and to evaluate cancer extension by examining lymphe node invasion during surgical procedures.
- During adjuvant surgery, the cervix is to be imaged by CLE to describe area altered by radio-chemotherapy.
- Ovaries and tubes are to be imaged by CLE before chemotherapy to diagnose cancer and after chemotherapy to detect residual tumor or fibrosis.
- Being tested
- Confocal Laser Endomicroscopy (CLE)
- Keywords
- Cellvizio, Endomicroscopy, Robot-assisted procedure, Cervix cancer, Endocervix cancer, Endometrium cancer, Ovarian cancer, Tubal cancer, Colposcopy, Hysteroscopy
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal Laser Endomicroscopy (CLE)Device
Also called Optical biopsy, Cellvizio
Real-time microscopic imaging of living tissue during the standard procedure
| Study group | Role | What they receive |
|---|---|---|
| Confocal Laser Endomicroscopy (CLE) | Experimental | The patient will undergo a 10 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs. Receives: Device: Confocal Laser Endomicroscopy (CLE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with adverse events, their type and severity.
Measured: 8 months
Secondary outcomes (1)
Number of interpretable images per organ and per pathology
Each sequence acquired during the cases will be annotated as to which organ it is, and the final diagnosis of the specimen (healthy, cancerous, inflammation, etc...). Thanks to this, a more complete atlas of images obtained gynaecological organs and conditions will be developed. This atlas will be used to describe image interpretation criteria for endomicroscopic images of various organs and conditions. This work will be done in conjunction by the investigators the histopathologist, and an Mauna Kea Technologies representative familiar with image interpretation in current endomicroscopy indications.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startJul 2014
- Primary completion18 Apr 2016
- Study completion18 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mauna Kea Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ERIC LAMBAUDIE, Principal investigator, IPC, Marseille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221076
- Sponsor's protocol ID
- GYN_MKT_2014
- Other IDs
- 2014-A00312-45
- Status last verified
- Aug 2017
- First submitted
- 12 Aug 2014
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Examinations or Surgical Procedures for Gynecological Cancers : a Feasibility Study
- ClinicalTrials.gov ID
- NCT02221076
- Acronym / sponsor ID
- GYN_MKT_2014
- Keywords
- Cellvizio, Endomicroscopy, Robot-assisted procedure, Cervix cancer, Endocervix cancer, Endometrium cancer, Ovarian cancer, Tubal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mauna Kea TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- 18 Apr 2016 (actual)
- Study completion
- 18 Apr 2016 (actual)
- First posted
- 20 Aug 2014 (estimated)
- 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.
The protocol aims at demonstrating the technical feasibility and safety of doing endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy, nCLE) during colposcopy, hysteroscopy, and surgical procedures (open surgery and laparoscopic robot assisted or not) to examine all pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.
Detailed description
This is a prospective study: about 75 patients (25 for each pathology) scheduled for a colposcopy or hysteroscopy examination or for a surgical treatment of the cervix/endocervix/endometrium/ovarian or tubal cancer will be enrolled. They will undergo the diagnostic consultation or surgical procedure, as per standard of care, plus an additional pCLE/nCLE procedure with the prototype probes, which will add between 5 and 10 minutes maximum to the examination.
The confocal miniprobe will be positioned against the surface of these organs or inside these same organs if the tumor is intratissular through a needle, and sequences will be acquired. Final diagnosis will be obtained for the patient, either through the result of the biopsies or through surgical pathology if the patient's lesion is surgically resected. Then imaging will be performed as well ex vivo on the resected specimens to provide additional stable imaging, and compare image quality to in vivo imaging.
The clinical endpoints of the study are:
- One or several Confocal Miniprobe designs optimized for use during colposcopy and hysteroscopy
- An optimized protocol of operations when using the designed Confocal Miniprobes during colposcopy and hysteroscopy as well as in the surgical setting, robotized or not (staining, use of accessories to hold the probes, etc...)
- A first atlas of endomicroscopic images obtained in the cervix, endocervix and endometrium
- The number, type and severity of recorded adverse events (to evaluate the safety).
Final objectives of CLE in gynecology:
- During colposcopic examination of the exocervix and conization, CLE is intended to be used to target biopsy and guide resection.
- During hysteroscopic examination of the endocervix, CLE is intended to be used to target biopsy and guide resection. Its ability to diagnose endocervical cancer will be evaluated.
- For endometrium cancer, CLE is to be used to target biopsy during hysteroscopy procedures and to evaluate cancer extension by examining lymphe node invasion during surgical procedures.
- During adjuvant surgery, the cervix is to be imaged by CLE to describe area altered by radio-chemotherapy.
- Ovaries and tubes are to be imaged by CLE before chemotherapy to diagnose cancer and after chemotherapy to detect residual tumor or fibrosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confocal Laser Endomicroscopy (CLE) | Experimental | Device: Confocal Laser Endomicroscopy (CLE)The patient will undergo a 10 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs. |
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)
- Patients scheduled for a colposcopy
- Patients scheduled for a hysteroscopy
- Patients scheduled for a surgical treatment for a suspected cervix/ endocervix/ endometrium lesion
- 18 years or older.
Key exclusion criteria (6 listed)
- Allergy to fluorescein
- Previous life-threatening allergic reactions and known hypersensitivity
- Pregnancy or breast-feeding
- History of cardio-pulmonary disease (including bronchial asthma)
- Restricted renal function
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 |
|---|---|---|
| Confocal Laser Endomicroscopy (CLE)Also: Optical biopsy, CellvizioReal-time microscopic imaging of living tissue during the standard procedure | Device | Confocal Laser Endomicroscopy (CLE) |
Primary outcome
The number of participants with adverse events, their type and severity.
Time frame: 8 months
1 secondary outcome
Number of interpretable images per organ and per pathology
Time frame: 8 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 29 Aug 2017.
- Individual participant dataSharing planned: No
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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.
ERIC LAMBAUDIE principal investigator
IPC, Marseille, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal Laser Endomicroscopy (CLE) in people with Cervix Cancer and Endometrium Cancer, run by Mauna Kea Technologies 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 6 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 29 Aug 2017. 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?
The number of participants with adverse events, their type and severity. (time frame: 8 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 29 Aug 2017.