MICRA - Pilot Study (MICRA)

October 5, 2021 updated by: Nantes University Hospital

Contribution of Confocal Microscopy in the Diagnosis of Acute Cell Rejection ACR in Lung Transplantation: Pilot Study

Acute cell rejection is a common complication of lung transplantation. The pathological diagnosis is based on the performance of transbronchial biopsies which are associated with a significant risk of potentially severe pneumothorax and hemoptysis. Confocal microscopy performed during bronchial endoscopy provides real-time images of the lungs on a microscopic scale. Thus, it is possible to visualize the alveoli, capillaries and intra-alveolar inflammatory cells. So far, work on the subject has only investigated the ability of this technique to determine the presence of acute cell rejection on post-fibroscopy analysis. Our hypothesis is that the absence of airway inflammation seen during the procedure by confocal microscopy is able to rule out the diagnosis of ACR and avoid the performance of transbronchial biopsies. Our job is to first assess the feasibility of the per-procedure evaluation and determine a decision algorithm. If the result is conclusive, a larger study will be carried out to assess the negative predictive value of this approach for the diagnosis of acute cell rejection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

During the patient's usual follow-up, if an ACR is suspected and it is decided to perform an endoscopy with transbronchial biopsies, the protocol is presented to the patient by the doctor in charge. If the patient agrees to participate in the study, consent is obtained. Collection on arrival of the patient's sex, age, weight, height, respiratory background leading to the patient's lung transplant.

According to the department's protocol: carrying out functional respiratory tests, a biological assessment (CBC, hemostasis and CRP) and a chest x-ray prior to the procedure except if there is another chest imaging dating less than 24 hours testifying to the absence of pneumothorax. Premedication with hydroxyzine, insertion of a peripheral venous route, verification of the patient's identity, anticoagulant or anti-aggregating treatment and potential allergy.

The fibroscopy is carried out according to the usual procedure of the service, namely: realization of 1 to 2 mg of hypnovel intravenously depending on the patient's tolerance, introduction of the fiberscope preferably via the nasal route, if impossible or contraindicated, the oral route is possible with the use of a bite block to protect the fiberscope. Visualization of the mobility of the vocal cords, trachea, carina and right and left bronchial tree up to the segmental level. Identification of the quality of the sutures and the possible presence of bronchial stenosis. Realization of a bronchial trap with bacteriological and mycological analysis. Performing a bronchoalveolar lavage (90cc of physiological serum, preferably in the middle lobe) with anatomopathological, virological, bacteriological, mycological and mycobacteriological analysis.

At this stage, the confocal microscopy procedure begins:

Taking pictures for post-procedure analysis in 4 different territories. For each territory, the investigator need to get a snapshot of a vascular structure and a snapshot of an alveolus.

Analysis per procedure: the same operator analyzes the alveoli deemed to be representative in real time. It determines the presence of intra-alveolar inflammatory cells and answers the question of the main criterion: possible interpretation in confocal microscopy? YES / NO, the clinical researcher immediately notes the answer in the CRF. Based on this per-procedure analysis, if he deems the interpretation possible, the operator declares if he concludes that pulmonary inflammation is present YES / NO, the response is noted immediately in the CRF.

The fibroscopy procedure is then resumed as usual in the department, namely:

Performing 5 to 6 transbronchial biopsies. The number of biopsies depends on the patient's tolerance and the occurrence of complications such as hemorrhage or pneumothorax. Checking at the end of the procedure for the absence of active intra-bronchial bleeding, followed by a frontal chest X-ray to check for the absence of pneumothorax (examination carried out routinely even in the event of bronchial endoscopy with simple BTB). If there are no complications and if the pathological analysis of the lung biopsies does not conclude that there is an acute cellular rejection, the patient can return home at the end of the day. If the pathologist concludes that there is a rejection or that there is a complication, the patient remains hospitalized for the time necessary for medical treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • CHU Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Follow-up by the Nantes University Hospital team for a lung transplant
  • Having given their consent
  • Clinical suspicion of acute cellular rejection OR systematic fibroscopy post transplantation to screen for acute asymptomatic rejection

Exclusion Criteria:

  • Minor or adult patient under guardianship and protected person
  • FEV1 <40% of theoretical at the time of inclusion
  • Bleeding disorder
  • Pneumothorax existing before the performance of the fibroscopy
  • Active smoking less than 1 year old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Microscopy confocal

The fibroscopy is carried out according to the usual procedure of the service. During the fibroscopy, for all patient, the confocal microscopy procedure begins.

After the end of confocal procedure, 5 to 6 transbronchial biopsies are performing
Procedure: microscopy confocal

At this stage, the confocal microscopy procedure begins:

Taking pictures for post-procedure analysis in 4 different territories. For each territory, the investigator need to get a snapshot of a vascular structure and a snapshot of an alveolus.

Analysis per procedure: the same operator analyzes the alveoli deemed to be representative in real time. It determines the presence of intra-alveolar inflammatory cells and answers the question of the main criterion: possible interpretation in confocal microscopy? YES / NO, the clinical researcher immediately notes the answer in the CRF. Based on this per-procedure analysis, if he deems the interpretation possible, the operator declares if he concludes that pulmonary inflammation is present YES / NO, the response is noted immediately in the CRF.

The fibroscopy procedure is then resumed as usual in the department, namely:

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determine ability of the operator
Time Frame: 1 day

The main objective of this study is to determine the ability of the operator to obtain and interpret confocal microscopy images per procedure. analyzes in real time the images provided by the confocal microscopy probe. the operator determines the presence of intra-alveolar inflammatory cells and evaluates the vessel wall.

On the basis of this per-procedure analysis, if the operator considers the interpretation possible, he declares whether he concludes that the presence of pulmonary inflammation is consistent with the diagnosis of rejection.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: 1 day
assess the adverse effects: patient comfort, procedure time and complications (hemoptysis, pneumothorax
1 day
ability of confocal microscopy to eliminate acute cellular rejection
Time Frame: 1 day
assess the ability of confocal microscopy to eliminate acute cellular rejection
1 day
Correlation confocal microscopy and proven infection
Time Frame: 1 day
to assess the correlation of the parameters observed in confocal microscopy associated with a proven infection (main differential diagnosis of acute cell rejection)
1 day
Correlation inter operator
Time Frame: 1 day
The correlation between the analysis per procedure by the operator and the analysis of the images by the second a posteriori expert
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut de Recherche en Santé Respiratoire des Pays de la Loire

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adrien TISSOT, MD, CHU Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 18, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 18, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC20_0201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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