Needle-based Confocal Laser Endomicroscopy in Fluoroscopy-guided Procedures

NCT02224885 | Completed

• 1 other identifier: MKT-IR-HEGP-2014
• Study Type: interventional
• Target: 6
• 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: lung and liver. This innovative study will involve the use of probe-based confocal laser endomicroscopy. The proposed study is a feasibility study.

Conditions

Lung Percutaneous Biopsy; Liver Percutaneous Biopsy

Keywords

Interventional radiology; Lung; Liver; Confocal endomicroscopy; Optical biopsy; Scanner; Fluoroscopy; CT; Computed Tomography; Radiofrequency Ablation; Fluorescein

Outcome Measures

Primary Outcomes (1)

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

  Assessment of the safety of inserting Cellvizio confocal miniprobe in the tumor (nor increase in bleeding or tumor cell dissemination) through the frequency, type and severity of adverse events

  Up to 1 week

Secondary Outcomes (4)

• Creation of image bank

  Up to 6 months

• Yield of nCLE (needle-based confocal laser endomicroscopy)-targeted Fluoroscopy-guided biopsies

  Up to 5 months

• Evaluation of potential benefits of the device combination

  Up to 5 months

• Assessment of accuracy and predictive value of interpretation criteria

  Up to 5 months

Study Arms (1)

addition of nCLE to help target biopsy

OTHER

The patient, scheduled for a liver or lung CT-guided percutaneous biopsy or ablation will undergo a probe-based confocal laser endomicroscopy procedure after the imaging 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: CT-guided percutaneous biopsy or ablation

Interventions

CT-guided percutaneous biopsy or ablation DEVICE

Standard interventional radiology procedure for a biopsy or ablation in the liver or in the lung

addition of nCLE to help target biopsy

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 lung or in liver, 18 years or older.
• Only subjects who have provided written informed consent for the study can be included in the study.

You may not qualify if:

• Known allergy to fluorescein
• Previous life-threatening allergic reactions and known hypersensitivity to contrast media
• Pregnancy or breast-feeding
• History of cardio-pulmonary disease (including bronchial asthma)
• Restricted renal function
• Elderly with diabetes mellitus
• Patients under a beta-blockers treatment

Sponsors & Collaborators

• Mauna Kea Technologies: lead

Study Sites (1)

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Study Officials

• Olivier PELLERIN

  HEGP, Paris, 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: July 28, 2014
• First Posted: August 25, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 27, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)