NCT02312167

Brief Summary

This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE). Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment. The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 11, 2016

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

November 28, 2014

Last Update Submit

February 10, 2016

Conditions

Cancer of Digestive SystemOvarian Cancer

Keywords

endomicroscopyoptical biopsyexploratory surgeryresection surgeryrobot-assistedperitoneum carcinosisinflammatoryrectum cancerliver cancerovarian cancerdigestive cancerpancreas cancerduodenum cancer

Outcome Measures

Primary Outcomes (1)

  • The number of participants with adverse events, their type and severity

    8 months

Secondary Outcomes (1)

  • The ease of manipulation of the robotized probe (grade 1 to 5)

    8 months

Other Outcomes (2)

  • the quality of real time communication between the pathologist lab and the OR (grade 1 to 5)

    8 months

  • number of interpretable images per organ, per contrast agent and per pathology

    8 months

Study Arms (1)

confocal laser endomicroscopy

EXPERIMENTAL

confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs

Device: confocal laser endomicroscopy

Interventions

confocal laser endomicroscopyDEVICE

probe-based and needle-based confocal laser endomicroscopy

Also known as: optical biopsy, Cellvizio
confocal laser endomicroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer
  • patient able to give written informed consent

You may not qualify if:

  • allergy to fluorescein
  • allergy to patented blue
  • allergy to ICG
  • previous life-threatening allergic reactions and known hypersensitivity
  • pregnancy or breast-feeding
  • history of cardio-pulmonary disease (including bronchial asthma)
  • restricted renal function
  • patient under a beta-blockers treatment
  • patient who cannot give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mutualiste Montsouris Institute

Paris, Paris, 75014, France

Location

Related Publications (1)

  • Fuks D, Pierangelo A, Validire P, Lefevre M, Benali A, Trebuchet G, Criton A, Gayet B. Intraoperative confocal laser endomicroscopy for real-time in vivo tissue characterization during surgical procedures. Surg Endosc. 2019 May;33(5):1544-1552. doi: 10.1007/s00464-018-6442-3. Epub 2018 Sep 19.

    PMID: 30232616DERIVED

MeSH Terms

Conditions

Digestive System NeoplasmsOvarian NeoplasmsRectal NeoplasmsLiver NeoplasmsGastrointestinal NeoplasmsPancreatic NeoplasmsDuodenal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsDigestive System DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesLiver DiseasesPancreatic DiseasesDuodenal Diseases

Study Officials

  • Brice GAYET, MD

    Mutualiste Montsouris Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 9, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 11, 2016

Record last verified: 2014-12

Locations

FR(1)