Ovarian Cancer Clinical Trial
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.
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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