Lung Clinical Trials

INTERLUNG Trial Summary

The current standard for biopsy-based diagnoses of rejection of lung transplants is the transbronchial biopsy (TBB) interpreted by histology using the ISHLT guidelines. This system has many weaknesses and errors, and many TBBs cannot be assessed by histology. To improve diagnostics in lung transplant biopsies, the Molecular Microscope® developed in kidney transplant biopsies has been adapted to lung transplant TBBs.  INTERLUNG will also explore the potential of mucosal biopsies (MB) from the third bronchial bifurcation (3B-MBs) to provide the same estimates as TBB, reducing the risks of biopsy complications. The first major publication is under review (21).​

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Study 

 

  1. Distinguish rejection (TCMR, ABMR) from acute injury. 

  2. Define the molecular phenotype of CLAD

  3. Develop a reference set of >1000 TBBs with molecular, histologic, DSA, and clinical data.

  4. Develop the Molecular Microscope system to report TBBs, incorporating rejection/injury principles discovered in kidney and heart.  

  5. Determine from experience how many TBB bites are needed to compensate for sampling error (alveolar content). Current biopsies performed under research protocols usually limit MMDx to one bite, but two or three may be needed to reduce sampling error. Because histology currently requires up to 10, MMDx-Lung can offer reduced risk.

  6. Report TBBs in real time (<48 hours from receiving the biopsy) to the clinician and obtain feedback from KOL clinicians from North American, European, and Australian Centers. An example of the current biopsy reporting format is shown below, using 152 TBB as the Reference Set. The picture shows the emerging Reference Set of TBBs and the location of the new biopsy.  The use of kidney rejection-associated molecules classifies biopsies into three clusters: relatively normal; TCMR-like changes; and a third class with injury, including endothelial abnormalities of unknown significance. Clinical input from KOLs will eventually establish the clinical significance of these changes (21-23).

  7. Explore the potential for a safer biopsy format by testing whether mucosal biopsies from the third bronchial bifurcation (3B-MB) can provide similar assessments to the TBB. This would offer more effective assessments at much lower risk.

 

 

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