Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Procedures.

August 28, 2017 updated by: Mauna Kea Technologies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13273
        • Institut Paoli Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Confocal Laser Endomicroscopy (CLE)
Real-time microscopic imaging of living tissue during the standard procedure
Other Names:
  • Cellvizio
  • Optical biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of participants with adverse events, their type and severity.
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of interpretable images per organ and per pathology
Time Frame: 8 months
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.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mauna Kea Technologies

Investigators

  • Principal Investigator: ERIC LAMBAUDIE, IPC, Marseille, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

April 18, 2016

Study Completion (Actual)

April 18, 2016

Study Registration Dates

First Submitted

August 12, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 20, 2014

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GYN_MKT_2014
  • 2014-A00312-45 (Other Identifier: Ref RCB given by ANSM ( French agency))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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