Lung Cryobiopsy Safety for Lung Cancer

Overseen By Mohit Chawla, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Antiplatelet therapy

Disqualifiers: Low oxygen, Coagulopathy, Pulmonary hypertension, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking antiplatelet therapy (medications that prevent blood clots) for more than 5 days before the procedure.

What data supports the effectiveness of the treatment Transbronchial cryobiopsy for lung cancer?

Research suggests that endobronchial cryobiopsy, a similar method, may help diagnose cancer faster by reducing diagnostic failures. Additionally, transbronchial cryobiopsy is considered a less invasive alternative to surgical lung biopsy, which could make it a useful tool in diagnosing lung conditions. ^{1 2 3 4 5}

Is transbronchial lung cryobiopsy safe for humans?

Transbronchial lung cryobiopsy is generally considered safe and is a less invasive alternative to surgical lung biopsy, with studies showing a good safety profile. However, safety outcomes can vary, and the procedure should be performed by experienced teams in specialized centers to minimize risks. ^{3 4 6 7 8}

How does lung cryobiopsy differ from other treatments for lung cancer?

Lung cryobiopsy is a less invasive method for obtaining lung tissue samples compared to traditional surgical lung biopsies. It uses a cryoprobe (a tool that freezes tissue) to collect samples, which may reduce the risks and complications associated with more invasive procedures. ^{1 3 4 9 10}

What is the purpose of this trial?

The purpose of this study is to find out whether a biopsy technique called transbronchial cryobiopsy (TBCB) is a safe alternative to the standard biopsy procedure (transbronchial forceps biopsy; TBFB). The study researchers think that TBCB may provide better biopsy samples to help diagnose lung disease.

Research Team

Or Kalchiem-Dekel, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with known or suspected lung cancer who need a biopsy to diagnose lung disease. It's not for those with severe pulmonary hypertension, unfit for bronchoscopy, pregnant women, low oxygen levels on minimal support, clear diagnosis from scans and tests, or serious blood clotting issues.

Inclusion Criteria

I may have cancer and need a lung biopsy to diagnose unclear lung issues.

Exclusion Criteria

I have high blood pressure in the lungs.

My diagnosis was confirmed with a CT scan.

Any patient deemed unfit to undergo bronchoscopy by the proceduralist

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transbronchial cryobiopsy as per the standardized cryo-biopsy protocol

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-cryobiopsy complications and safety

2 years

Treatment Details

Interventions

• Transbronchial cryobiopsy

Trial Overview The study is testing the safety of transbronchial cryobiopsy (TBCB) compared to the standard forceps biopsy in diagnosing lung diseases. Researchers believe TBCB might provide better samples for accurate diagnoses.

Participant Groups

Group I: Transbronchial cryobiopsy Experimental Treatment 1 Intervention

All study participants will undergo transbronchial biopsies via our proposed standardized cryo-biopsy protocol in place of the traditional forceps transbronchial biopsy that is typically used at MSK.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

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]

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]

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]

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]

References

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

Diagnostic Yield and Complications of Transbronchial Lung Cryobiopsy for Interstitial Lung Disease. A Systematic Review and Metaanalysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Endobronchial cryobiopsy may shorten the time to cancer diagnosis: a retrospective study. [2023]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Feasibility study of cryobiopsy for practical pathological diagnosis of primary lung cancer including immunohistochemical assessment. [2021]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Transbronchial Cryobiopsy in Interstitial Lung Disease: Safety of a Standardized Procedure. [2021]

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

High Complication Rate after Introduction of Transbronchial Cryobiopsy into Clinical Practice at an Academic Medical Center. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Thin bronchoscopic cryobiopsy using a nasobronchial tube. [2022]