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

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ClinicalTrials.gov Identifier: NCT02221076
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Mauna Kea Technologies

Brief 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 not) to examine all pelvic tissues including cervix, uterus, adnexia, peritoneum, normal and pathologic aspect.

Condition or disease Intervention/treatment Phase
Cervix Cancer Endometrium Cancer Ovarian Cancer Carcinoma in Situ of Fallopian Tube Device: Confocal Laser Endomicroscopy (CLE) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Examinations or Surgical Procedures for Gynecological Cancers : a Feasibility Study
Study Start Date : July 2014
Actual Primary Completion Date : April 18, 2016
Actual Study Completion Date : April 18, 2016


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:
  • Optical biopsy
  • Cellvizio




Primary Outcome Measures :
  1. The number of participants with adverse events, their type and severity. [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. 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.



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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:

  • 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

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): NCT02221076


Locations
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France
Institut Paoli Calmettes
Marseille, France, 13273
Sponsors and Collaborators
Mauna Kea Technologies
Investigators
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Principal Investigator: ERIC LAMBAUDIE IPC, Marseille, France

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Responsible Party: Mauna Kea Technologies
ClinicalTrials.gov Identifier: NCT02221076     History of Changes
Other Study ID Numbers: GYN_MKT_2014
2014-A00312-45 ( Other Identifier: Ref RCB given by ANSM ( French agency) )
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mauna Kea Technologies:
Cellvizio
Endomicroscopy
Robot-assisted procedure
Cervix cancer
Endocervix cancer
Endometrium cancer
Ovarian cancer
Tubal cancer
Colposcopy
Hysteroscopy

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Carcinoma in Situ
Uterine Cervical Neoplasms
Endometrial Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases