Cryo Biopsy/Ablation for Lung Disease

(CT0129 Trial)

Recruiting at 1 trial location

Overseen By Moishe Liberman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Organ donor ineligible, healthy individuals

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for performing lung biopsies using a cryogenic catheter, a special cooling tool that freezes and removes tissue samples. The goal is to identify the safest and most effective way to collect these samples from the lungs, potentially improving the diagnosis and treatment of lung diseases. The trial seeks patients already scheduled for lung transplant surgery.

As an unphased trial, this study allows patients to contribute to innovative research that could enhance future lung disease diagnosis and treatment.

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 prior data suggests that this methodology is safe for lung disease?

Research shows that cryobiopsy, a technique for taking lung tissue samples, is generally safe and effective. Studies have found that cryobiopsy can be a less invasive way to collect lung tissue, aiding in the diagnosis of lung issues. This method is particularly useful for conditions like interstitial lung diseases.

Another review found that cryobiopsy improves the accuracy of lung diagnoses when used alongside other sampling methods. However, risks such as bleeding can occur. Overall, these studies suggest that cryobiopsy is well-tolerated in many cases, but like any procedure, it has its risks.

This information is based on past research and aims to help you understand the safety of the cryobiopsy process. If considering joining a trial, consulting healthcare professionals is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cryo Ex Vivo technique because it offers a new way to handle lung disease tissue samples. Unlike traditional biopsy methods, this approach uses cryo technology to both biopsy and ablate, or remove, diseased tissue with precision. This method may provide higher quality specimens, which can lead to better models for studying lung disease. By improving the quality and stability of these models, researchers hope to enhance understanding and treatment of lung conditions.

What evidence suggests that this cryo biopsy/ablation method is effective for lung disease?

Research has shown that cryobiopsy, a technique using extreme cold to collect tissue samples, effectively diagnoses lung diseases. Studies indicate an accuracy rate of up to 86%, providing larger and more precise samples than traditional methods. This accuracy helps doctors better understand lung conditions, leading to improved treatment plans. In this trial, the Ex Vivo Cryo technique will evaluate its effectiveness in obtaining high-quality tissue specimens. Cryoablation, which uses cold to destroy unhealthy tissue, also shows promise for treating lung lesions. Both techniques have the potential to improve the diagnosis and treatment of lung diseases. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Cryo Ex Vivo

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Cryosurgery has been effectively used in bronchoscopy for local treatment of tumors and stenoses, enhancing the ability to perform high-quality biopsies.

Transbronchial cryobiopsy is particularly important for diagnosing diffuse lung diseases and conducting molecular analysis of malignant lung tumors, providing valuable insights for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cryobiopsy]. Böckeler, M.[2020]

Cryobiopsy (CB) is emerging as a promising technique for diagnosing lung diseases, particularly interstitial lung disease, as it may provide larger biopsy samples and reduce damage to the tissue compared to traditional methods.

This report highlights a case of acute exacerbation of interstitial lung disease (AEILD) following cryobiopsy, indicating that while CB has advantages, there may still be risks associated with the procedure that need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Exacerbation of Interstitial Lung Disease After Cryobiopsy. Tomic, R., Cortes-Puentes, GA., Murugan, P., et al.[2022]

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]

Transbronchial lung cryobiopsy (TBLC) is a safe and effective method for diagnosing interstitial lung disease (ILD), with a total of 159 procedures showing a low overall complication rate, including a 1.9% 30-day mortality rate not attributed to the procedure.

Hospitalized patients experienced higher rates of complications such as pneumothorax (24% vs 9.9% in outpatients) and ICU transfers (12% vs 2.1%), indicating that patient status may influence the risk profile of TBLC procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of performing transbronchial lung cryobiopsy on hospitalized patients with interstitial lung disease. Cooley, J., Balestra, R., Aragaki-Nakahodo, AA., et al.[2019]

Cryoablation for lung tumors was evaluated in 117 patients across 193 sessions, showing it can be performed with acceptable complication rates, including pneumothorax (61.7%) and pleural effusion (70.5%).

The study identified significant predictors for complications, such as a greater number of cryoprobes used, which increased the risk of pneumothorax and hemoptysis, highlighting the importance of technique in minimizing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoablation of lung tumors: feasibility and safety. Inoue, M., Nakatsuka, S., Yashiro, H., et al.[2022]

In a study of 257 patients undergoing transbronchial lung cryobiopsy (TBLC) for suspected interstitial lung disease, complications occurred in 15.2% of cases, with 5.4% requiring hospital admission on the same day.

Factors such as a modified MRC dyspnoea score of 2 or higher, forced vital capacity (FVC) below 50%, and a Charlson Comorbidity Index score of 2 or more were identified as predictors for early and overall hospital admissions following the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications and hospital admission in the following 90 days after lung cryobiopsy performed in interstitial lung disease. Aburto, M., Pérez-Izquierdo, J., Agirre, U., et al.[2021]

In a study involving 60 patients, both the 1.7-mm and 1.9-mm cryoprobes used for transbronchial lung cryobiopsy showed similar high diagnostic yields (100% for the 1.9-mm and 93.3% for the 1.7-mm), indicating that both tools are effective for diagnosing diffuse parenchymal lung diseases.

The safety profiles of both cryoprobes were comparable, with no significant differences in complication rates, such as pneumothorax or bleeding, and no severe adverse events reported, suggesting that both methods are safe for patients.

NCBI (Pubmed)

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. Ravaglia, C., Sultani, F., Piciucchi, S., et al.[2023]

Cryobiopsy, a new bronchoscopic technique for lung biopsy, can obtain larger and better-preserved tissue samples than traditional methods, with a diagnostic yield of 70% to 80% for diffuse parenchymal lung disease.

The variability in cryobiopsy techniques and definitions of diagnostic yield across different centers makes it challenging to compare results and assess complications, highlighting the need for standardized protocols and further research.

NCBI (Pubmed)

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. Lentz, RJ., Argento, AC., Colby, TV., et al.[2020]

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 are a safe diagnostic procedure for interstitial lung disease, with a low complication rate (28% pneumothorax and 21% moderate hemorrhage) and a very low mortality rate of 0.4% over three months.

The procedure has a diagnostic yield of 72%, with factors like biopsy size and the presence of alveolar tissue improving the likelihood of reaching a consensus diagnosis in 82% of cases.

NCBI (Pubmed)

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. Kronborg-White, S., Sritharan, SS., Madsen, LB., et al.[2022]

Transbronchial lung cryobiopsy (TBLC) is a safe procedure with a low complication rate (5% pneumothorax) and no severe adverse events reported, making it a viable alternative to surgical lung biopsy (SLB) for diagnosing interstitial lung diseases.

The diagnostic agreement between TBLC and SLB was significantly improved when assessed in a multidisciplinary discussion, achieving 65.4% agreement for IPF/non-IPF diagnoses, indicating that TBLC can provide reliable diagnostic information comparable to SLB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concordance between transbronchial lung cryobiopsy and surgical lung biopsy for interstitial lung disease in the same patients. Baba, T., Takemura, T., Okudela, K., et al.[2023]

Cryoprobe transbronchial lung biopsy is a new technique that provides larger biopsy samples, potentially improving the diagnostic yield for lung diseases compared to conventional methods, although its clinical role is still being defined.

Cryotherapy has been established as a safe and effective method for treating endobronchial lesions and is being explored for its efficacy in lung cancer treatment and foreign body extraction from the airways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryotechnology in diagnosing and treating lung diseases. Tomic, R., Podgaetz, E., Andrade, RS., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5542930/

Transbronchial cryobiopsy for diffuse parenchymal lung disease This review reported a diagnostic yield of 78% (range, 74–98%) when cryobiopsies were used in isolation for diagnosis and 86% (range, 51–98%) when a ...

2. withpower.com withpower.com/trial/phase-lung-diseases-7-2023-0ebf1

Cryo Biopsy/Ablation for Lung Disease (CT0129 Trial) Cryotechnology, used in cryobiopsy and cryotherapy, has shown effectiveness in diagnosing and treating lung diseases by providing larger biopsy samples and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0012369221009417

Diagnostic Outcomes and Safety of Cryobiopsy Added to ... Among them, 22 lesions were diagnosable by cryobiopsy exclusively, which improved the rate of diagnosis by 8.6%. Advantages of the use of cryobiopsy were the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12082924/

Cryopreservation of human lung tissue for 3D ex vivo analysis Cryopreservation of human lung tissue is a strategy to address these limitations by generating cryopreserved biobanks of donors in the ex vivo study of ...

5. ccts.amegroups.org ccts.amegroups.org/article/view/89093/html

The rising role of cryobiopsy in diagnosis of pulmonary disorders This review aims to address the current known data of the application of cryobiopsy in evaluation of ILD, peripheral lung nodules, and lymph node evaluations.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10553789/

Safety, utility and clinical efficacy of cryobiopsy of lung in ... Cryobiopsy is a valuable diagnostic tool in childhood interstitial lung diseases, which offers a less invasive option for obtaining lung tissue samples with a ...

7. mdpi.com mdpi.com/2075-4418/13/18/2886

Utility & Safety of Bronchoscopic Cryotechniques: Review We present a review of the literature on the diagnostic and therapeutic utility of bronchoscopy-guided cryosurgical procedures and their safety profile.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/crj.13669

Cryobiopsy in Interstitial Lung Diseases Feasible The aim of this study is to investigate the ability of pCLE to distinguish fibrotic pulmonary issues from normal lung disease and the safety and feasibility of ...