Needle-based Confocal Laser Endomicroscopy in CT-guided Percutaneous Procedures

NCT02288104 | Completed

• 1 other identifier: MKT-IR-NHC-2014
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective study in order to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: Kidneys and liver. This innovative study will involve the use of probe-based confocal laser endomicroscopy. The proposed study is a feasibility study.

Conditions

Liver Percutaneous Biopsy or Ablation; Kidney Percutaneous Biopsy or Ablation

Keywords

Interventional Radiology; Liver; Kidney; Confocal endomicroscopy; Optical Biopsy; Scanner; Fluoroscopy; CT; Computed Tomography; Radiofrequency Ablation; Fluorescein

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy (sensitivity specificity) of endomicroscopy as compared to histopathology

  Assessment of the accuracy of Cellvizio confocal mini probe imaging guided by fluoroscopy at the tumor boundary compared with traditional histopathology from physical biopsies

  up to 2 weeks

Secondary Outcomes (4)

• Measure adverse events frequency in the use of mini probes on the tumor

  Up to 1 week

• Classification of endomicroscopy images from benign and malignant conditions

  Up to 6 months

• Percentage of biopsies guided by nCLE (needle-based Confocal Laser Endomicroscopy) which provide a definitive diagnosis as a measure of efficiency of endomicroscopy-targeted biopsies compared to traditional needle biopsies

  Up to 5 months

• Number of patients for whom endomicroscopy could have affected the clinical workflow

  Up to 5 months

Study Arms (1)

needle based confocal endomicroscopy

OTHER

The patient, scheduled for a standard liver or kidney percutaneous biopsy or ablation will undergo a needle-based confocal laser endomicroscopy procedure during the procedure. The objectives of this study are to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure and determine whether it is technically feasible to obtain images from Cellvizio during an interventional radiology procedure.

Device: needle based confocal endomicroscopy

Interventions

needle based confocal endomicroscopy DEVICE

real time imaging of living tissue at microscopic scale, through a needle.

needle based confocal endomicroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to have an interventional radiology procedure for needle-biopsy or radiofrequency ablation purposes in liver or Kidney.
• Only subjects who have provided written informed consent for the study can be included in the study.

You may not qualify if:

• Patients have a known allergy to fluorescein
• Patient is Pregnant or breast-feeding
• Patient under judiciary control
• Patient under the tutelage of a guardian
• Patient unable to sign the information consent form (in case of an emergency situation or difficulty in understanding the information)

Sponsors & Collaborators

• Mauna Kea Technologies: lead

Study Sites (1)

Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Study Officials

• Afshin Gangi

  NHC, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 11, 2014
• Study Start: January 1, 2015
• Primary Completion: March 17, 2017
• Study Completion: March 17, 2017
• Last Updated: August 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)