Cryo Biopsy/Ablation for Lung Disease

(CT0129 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Organ donor ineligible, healthy individuals

No Placebo Group

Trial Summary

What is the purpose of this trial?

Developing a standardized methodology for the use of novel cryogenic catheters for transbronchial cryobiopsy and cryoablation of pulmonary lesions.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Cryo Ex Vivo for lung disease?

Cryotechnology, used in cryobiopsy and cryotherapy, has shown effectiveness in diagnosing and treating lung diseases by providing larger biopsy samples and safely removing obstructions in the airways. It has been used successfully in lung cancer treatment and is emerging as a promising method for diagnosing interstitial lung diseases with fewer complications compared to surgical biopsies. ^{1 2 3 4 5}

Is cryo biopsy/ablation safe for lung disease treatment?

Cryo biopsy and ablation techniques, like transbronchial lung cryobiopsy, are generally considered safe and have a good safety profile for diagnosing lung diseases, though they are not without risks. These procedures should be performed by experienced teams in specialized centers to minimize complications. ^{6 7 8 9 10}

How is cryo biopsy/ablation treatment different from other treatments for lung disease?

Cryo biopsy/ablation is unique because it uses extreme cold to obtain larger and better-preserved lung tissue samples compared to traditional methods, which can improve diagnosis accuracy for lung diseases. This technique also allows for the removal of obstructions in the airways and is being explored for its potential in treating lung cancer, making it a versatile tool in both diagnosis and treatment. ^{1 2 11 12 13}

Research Team

Eligibility Criteria

This trial is for patients who are undergoing lung transplant surgery. It's not open to individuals who can't donate their lungs or those who are healthy without any lung disease.

Inclusion Criteria

I am scheduled for or have had a lung transplant.

Exclusion Criteria

I cannot donate my lungs.

People who are in good health

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ex Vivo Cryo Procedure

Multiple procedures will be performed on ex-vivo human lung models to develop a standardized technique for transbronchial cryobiopsy and cryoablation of pulmonary lesions.

48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cryo Ex Vivo (Procedure)

Trial Overview The study is testing a new technique using cryogenic catheters for biopsy and treatment of lung lesions, aiming to establish a standard method in an ex-vivo (outside the body) human lung model.

Participant Groups

Group I: Ex Vivo Cryo Experimental Treatment 1 Intervention

Multiple procedures will be performed to each model in order to accomplish the objectives of the study. Tissue samples will be taken from the models and images will be performed. This will allow us to determine which configuration is the optimal for obtaining the more effective and stable models that could offer the best quality specimens as well.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Dr. Réjean Lapointe

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Medical Officer since 2023

MD from Université de Montréal

Dr. Fabrice Brunet

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Executive Officer since 2015

MD from Université de Montréal

Findings from Research

Transbronchial lung cryobiopsy is a promising technique for diagnosing interstitial lung disease and thoracic malignancies, offering a high diagnostic yield and a good safety profile compared to traditional surgical lung biopsies, which carry higher risks.

Cryosurgical techniques, including cryorecanalization, are effective for managing central airway obstructions, but they require specialized centers and experienced teams to minimize complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility and Safety of Bronchoscopic Cryotechniques-A Comprehensive Review. Husnain, SMN., Sarkar, A., Huseini, T.[2023]

Transbronchial cryobiopsies taken for 3 seconds yield the largest biopsy size while minimizing complications, such as severe bleeding and pneumothorax, based on a study involving two anesthetized sheep and 49 biopsies.

The study found a significant positive correlation between freezing time and biopsy size, with all samples showing preserved lung tissue architecture and minimal artefacts, indicating the method's efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Transbronchial Lung Cryobiopsy Size and Freezing Time: A Prognostic Animal Study. Ing, M., Oliver, RA., Oliver, BG., et al.[2022]

Cryobiopsy of lung tissue yields significantly larger specimens compared to traditional transbronchial forceps biopsies, with an average size of 17.1 mm² versus 3.8 mm², enhancing the potential for accurate diagnosis.

Cryobiopsy samples more frequently contain intact alveolar tissue without artefacts, suggesting improved quality and diagnostic capability for both neoplastic and non-neoplastic lung diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morphometrical analysis of transbronchial cryobiopsies. Griff, S., Ammenwerth, W., Schönfeld, N., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cryotechnology in diagnosing and treating lung diseases. [2015]

2. Germany pubmed.ncbi.nlm.nih.gov

[Cryobiopsy]. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Acute Exacerbation of Interstitial Lung Disease After Cryobiopsy. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Integration of cryobiopsies for interstitial lung disease diagnosis is a valid and safe diagnostic strategy-experiences based on 250 biopsy procedures. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Concordance between transbronchial lung cryobiopsy and surgical lung biopsy for interstitial lung disease in the same patients. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Utility and Safety of Bronchoscopic Cryotechniques-A Comprehensive Review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Safety of performing transbronchial lung cryobiopsy on hospitalized patients with interstitial lung disease. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Percutaneous cryoablation of lung tumors: feasibility and safety. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Complications and hospital admission in the following 90 days after lung cryobiopsy performed in interstitial lung disease. [2021]

10. Spain pubmed.ncbi.nlm.nih.gov

Diagnostic yield and safety of transbronchial lung cryobiopsy for diffuse parenchymal lung diseases diagnosis: Comparison between 1.7-mm and 1.9-mm probes. [2023]

11. China pubmed.ncbi.nlm.nih.gov

Transbronchial cryobiopsy for diffuse parenchymal lung disease: a state-of-the-art review of procedural techniques, current evidence, and future challenges. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Transbronchial Lung Cryobiopsy Size and Freezing Time: A Prognostic Animal Study. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Morphometrical analysis of transbronchial cryobiopsies. [2022]