MICRA - Pilot Study

NCT04536883 | Completed

• 1 other identifier: RC20_0201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rejection Lung Transplant

Keywords

Confocal Microscopy; Acute cell rejection; Lung Transplantation

Outcome Measures

Primary Outcomes (1)

• Determine ability of the operator

  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 Outcomes (4)

• Adverse effects

  1 day

• ability of confocal microscopy to eliminate acute cellular rejection

  1 day

• Correlation confocal microscopy and proven infection

  1 day

• Correlation inter operator

  1 day

Study Arms (1)

Microscopy confocal

EXPERIMENTAL

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

Interventions

microscopy confocal PROCEDURE

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:

Microscopy confocal

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Minor or adult patient under guardianship and protected person
• Bleeding disorder
• Pneumothorax existing before the performance of the fibroscopy
• Active smoking less than 1 year old

Sponsors & Collaborators

• Nantes University Hospital: lead
• Institut de Recherche en Santé Respiratoire des Pays de la Loire: collaborator

Study Sites (1)

CHU Nantes

Nantes, France

Location

MeSH Terms

Interventions

Microscopy, Confocal

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Adrien TISSOT, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: September 3, 2020
• Study Start: September 23, 2020
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-03

Locations

FR (1)