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.12345
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.678910
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.12111213
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 OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Ex Vivo CryoExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
CHUMMontréal, Canada
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
References
Cryotechnology in diagnosing and treating lung diseases. [2015]Cryotechnology has been used in treating lung cancer for many years, now it is emerging to have a new indication in diagnosing lung diseases. Cryoprobe transbronchial lung biopsy has been introduced into clinical practice as a new technique, providing a larger biopsy specimen, potentially improving the diagnostic yield of transbronchial biopsies in parenchymal lung diseases. Although recent small pilot studies suggest that cryotransbronchial lung biopsies are comparable to conventional transbronchial biopsies in terms of diagnostic yield and safety profile in lung transplant patients, cryoprobe transbronchial lung biopsy is still being evaluated and its role in clinical practice is not well defined. Cryotherapy has been proven as a safe and effective method to debulk endobronchial lesions, providing palliation for advanced central obstructive tumors. Its use and efficacy is also studied in direct cryosurgery and percutaneous application in lung cancer. Cryoprobes can also be used to extract foreign bodies from the airways by causing cryoadhesion. We aim to summarize the therapeutic and diagnostic application of cryotechnology in pulmonary diseases.
[Cryobiopsy]. [2020]Cryosurgery has been successfully in bronchoscopy for several years. In addition to the local therapy of tumors and stenoses, cryo extraction enables the endobronchial and transbronchial extraction of large, high-quality biopsies. This is with regard to the diagnosis of diffuse lung diseases and the molecular analysis of malignant lung tumors of outstanding importance. This article explains the method and implementation of transbronchial cryobiopsy.
Acute Exacerbation of Interstitial Lung Disease After Cryobiopsy. [2022]Cryotherapy has been used in treatment of lung cancer for decades. The utility of cryotechnology in diagnosis of lung diseases is emerging and gaining popularity. Cryobiopsy (CB) of the lung, when compared with conventional transbronchial forceps lung biopsy, has proposed to have a higher diagnostic yield in interstitial lung disease by providing larger biopsy specimen and less crush artifact. Acute exacerbation of interstitial lung disease (AEILD) has been well described with surgical lung biopsies and, rarely, with conventional transbronchial forceps biopsy. The incidence of AEILD after CB is not known. Here we are presenting a case of AEILD after CB.
Integration of cryobiopsies for interstitial lung disease diagnosis is a valid and safe diagnostic strategy-experiences based on 250 biopsy procedures. [2022]Transbronchial cryobiopsies has become increasingly used in the diagnostic workup in patients suspected of having interstitial lung disease. The procedure is associated with less complications, morbidity and mortality compared to surgical lung biopsies although with a diagnostic yield that is not as high, but close to that of surgical lung biopsies. The aim of the present study was to describe the complications and diagnostic yield and their prognostic factors.
Concordance between transbronchial lung cryobiopsy and surgical lung biopsy for interstitial lung disease in the same patients. [2023]The diagnostic accuracy and safety of transbronchial lung cryobiopsy (TBLC) via a flexible bronchoscope under sedation compared with that of surgical lung biopsy (SLB) in the same patients is unknown.
Utility and Safety of Bronchoscopic Cryotechniques-A Comprehensive Review. [2023]Cryosurgical techniques are employed for diagnostic and therapeutic bronchoscopy and serve as important tools for the management of pulmonary diseases. The diagnosis of interstitial lung disease requires multidisciplinary team discussions after a thorough assessment of history, physical exam, computed tomography, and lung-function testing. However, histological diagnosis is required in selected patients. Surgical lung biopsy has been the gold standard but this can be associated with increased morbidity and mortality. Transbronchial lung cryobiopsy is an emerging technique and multiple studies have shown that it has a high diagnostic yield with a good safety profile. There is wide procedural variability and the optimal technique for cryobiopsy is still under investigation. There is emerging data that demonstrate that cryobiopsy is safe and highly accurate in the diagnosis of thoracic malignancies. Furthermore, cryorecanalization procedures are a useful adjunct for the palliation of tumors in patients with central airway obstruction. One should keep in mind that these procedures are not free from complications and should be carried out in a specialized center by a trained and experienced bronchoscopy team. We present a review of the literature on the diagnostic and therapeutic utility of bronchoscopy-guided cryosurgical procedures and their safety profile.
Safety of performing transbronchial lung cryobiopsy on hospitalized patients with interstitial lung disease. [2019]Transbronchial lung cryobiopsy (TBLC) has become a popular option for tissue diagnosis of interstitial lung disease (ILD), however reports vary regarding the safety of this procedure. Herein, we evaluate the safety of transbronchial cryobiopsy in hospitalized patients, comparing adverse events to outpatient procedures.
Percutaneous cryoablation of lung tumors: feasibility and safety. [2022]To evaluate the safety and feasibility of cryoablation for lung tumors as well as the incidence of, and risk factors for, complications.
Complications and hospital admission in the following 90 days after lung cryobiopsy performed in interstitial lung disease. [2021]Transbronchial lung cryobiopsy (TBLC) is an emerging technique for the diagnosis of interstitial lung disease (ILD), but its risk benefit ratio has been questioned. The objectives of this research were to describe any adverse events that occur within 90 days following TBLC and to identify clinical predictors that could help to detect the population at risk.
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]transbronchial lung cryobiopsy has been recently accepted as a valid and less invasive alternative to surgical lung biopsy. The purpose of this randomized controlled study was to evaluate, for the first time, the quality and safety of biopsy specimens obtained by using the new disposable 1.7-mm cryoprobe compared with the standard re-usable 1.9 mm cryoprobe in the diagnosis of diffuse parenchymal lung diseases.
Transbronchial cryobiopsy for diffuse parenchymal lung disease: a state-of-the-art review of procedural techniques, current evidence, and future challenges. [2020]Transbronchial lung biopsy with a cryoprobe, or cryobiopsy, is a promising new bronchoscopic biopsy technique capable of obtaining larger and better-preserved samples than previously possible using traditional biopsy forceps. Over two dozen case series and several small randomized trials are now available describing experiences with this technique, largely for the diagnosis of diffuse parenchymal lung disease (DPLD), in which the reported diagnostic yield is typically 70% to 80%. Cryobiopsy technique varies widely between centers and this predominantly single center-based retrospective literature heterogeneously defines diagnostic yield and complications, limiting the degree to which this technique can be compared between centers or to surgical lung biopsy (SLB). This review explores the broad range of cryobiopsy techniques currently in use, their rationale, the current state of the literature, and suggestions for the direction of future study into this promising but unproven procedure.
Evaluation of Transbronchial Lung Cryobiopsy Size and Freezing Time: A Prognostic Animal Study. [2022]Transbronchial lung biopsy using a cryoprobe is a novel way of sampling lung parenchyma. Correlation of freezing time with biopsy size and complications has not been evaluated in vivo.
Morphometrical analysis of transbronchial cryobiopsies. [2022]The recent introduction of bronchoscopically recovered cryobiopsy of lung tissue has opened up new possibilities in the diagnosis of neoplastic and non-neoplastic lung diseases in various aspects. Most notably the morphological diagnosis of peripheral lung biopsies promises to achieve a better yield with a high quality of specimens. To better understand this phenomenon, its diagnostic options and perspectives, this study morphometrically compares 15 cryobiopsies and 18 transbronchial forceps biopsies of peripheral lung tissue a priori without considering clinical hit ratio or integration of results in the clinical diagnostic processing. Cryotechnically harvested specimens were significantly larger (mean: 17.1 ± 10.7 mm2 versus 3.8 ± 4.0 mm2) and contained alveolar tissue more often. If present, the alveolar part in cryobiopsies exceeded the one of forceps biopsies. The alveolar tissue of crybiopsy specimens did not show any artefacts. Based on these results cryotechnique seems to open up new perspectives in bronchoscopic diagnosis of lung disease.