Clinical trial NCT02224885: Needle-based Confocal Laser Endomicroscopy in Fluoroscopy-guided Procedures
Official title: Needle-based Confocal Laser Endomicroscopy in Fluoroscopy-guided Procedures for Lung Applications (Biopsies and Ablation) and Liver Procedures in Interventional Radiology: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Percutaneous Biopsy
Liver Percutaneous Biopsy
Keywords: Interventional radiology
Lung
Liver
Confocal endomicroscopy
Optical biopsy
Scanner
Fluoroscopy
CT
Computed Tomography
Radiofrequency Ablation
Fluorescein
Lead sponsor: Mauna Kea Technologies
Sponsor class: INDUSTRY
First posted: 2014-08-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Interventional radiology is a medical sub-specialty of radiology which utilizes minimally-invasive image-guided procedures to diagnose and treat diseases in nearly every organ. The concept behind interventional radiology is to diagnose and treat patients using less invasive techniques currently available in order to minimize risk to the patient and improve health outcomes.

For many years, surgery was the only treatment available for many conditions. Today, interventional radiology treatments are frst-line care for a wide variety of conditions. Patients should be offered the least invasive option frst. It is important to get a second opinion and know all of your treatment options before consenting to any procedure or surgery. Interventional radiologists are specialists in minimally invasive treatments, have a unique breadth of training and provide consults to every type of specialist.

Surgical removal of liver tumors offers the best chance for a cure. Unfortunately, liver tumors are often inoperable because the tumor may be too large, or has grown into major blood vessels or other vital structures. Sometimes, many small tumors are spread throughout the liver, making surgery too risky or impractical. Surgical removal is not possible for more than two-thirds of primary liver cancer patients and 90 percent of patients with secondary liver cancer.

The objectives of this study are to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure in two main indications: lung and liver.

The goal is to determine whether:

* Cellvizio insertion during the interventional procedure leads to change in known adverse events / serious adverse events rate during and one month after the procedure
* It is technically feasible to obtain images from Cellvizio during an interventional radiology procedure
* Cellvizio is a helpful assistance to increase the efficacy of biopsy which require to evaluate its accuracy eg. the predictive value of Cellvizio compared to pathology results.

Secondary goals are to assess:

* Benefit of spatial accuracy for the yield of the biopsy procedure and potential subsequent intervention, e.g. radiofrequency ablation.
* Regarding lung biopsies and lung ablation, potential increase of a database to refine image interpretation criteria with pathologists.
* In liver application, the goal is to build a database of images and define image interpretation criteria with pathologists to start image interpretation work.
* The predictive value of biopsies with Cellvizio assistance for lung or liver tumor biopsies.

For both applications, technical feedback from the physicians is expected on how they think the combined use of the devices could change the care path. E.g. a certain step in the workflow might become obsolete or the workflow could lead to fewer patient visits.

For the safety of this protocol, the use of endomicroscopy will not change in any way the patient management and standard procedure, including the diagnosis nor treatment decisions. All the adverse events / serious adverse events will be noted during the procedure and one week after the procedure.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Measure adverse events frequency in the use of mini probes on the tumor
timeFrame: Up to 1 week
Secondary outcomes:
measure: Creation of image bank
timeFrame: Up to 6 months
measure: Yield of nCLE (needle-based confocal laser endomicroscopy)-targeted Fluoroscopy-guided biopsies
timeFrame: Up to 5 months
measure: Evaluation of potential benefits of the device combination
timeFrame: Up to 5 months
measure: Assessment of accuracy and predictive value of interpretation criteria
timeFrame: Up to 5 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
affiliation: HEGP, Paris, France
name: Olivier PELLERIN
role: PRINCIPAL_INVESTIGATOR
References: