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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a new biopsy technique, transbronchial cryobiopsy (TBCB), safely and effectively collects lung tissue samples for diagnosing lung disease. Researchers believe this method might provide better samples than the current standard, which uses forceps. This could benefit individuals with lung nodules or lung diseases that are difficult to diagnose. Those with a known or suspected cancer diagnosis and uncertain lung issues may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that transbronchial cryobiopsy is safe for lung cancer diagnosis?

Research has shown that transbronchial cryobiopsy (TBCB) is a safe method for diagnosing lung diseases, including lung cancer. One study involving 257 patients demonstrated that TBCB successfully identified lung problems. Importantly, this study found that TBCB did not increase the risk of complications like bleeding or a collapsed lung compared to the usual method. Another study found that TBCB is safe and effective, even for older patients. These findings suggest that TBCB is well-tolerated and might be a safer option with fewer risks than traditional biopsy methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transbronchial cryobiopsy is unique because it uses extreme cold to obtain lung tissue samples, which can provide more intact and larger samples compared to the traditional forceps biopsy. Unlike standard bronchoscopy methods that can crush or damage the tissue, cryobiopsy offers clearer histological details, potentially leading to more accurate diagnoses. Researchers are excited about this technique because it could improve diagnostic precision and safety for patients undergoing evaluation for lung cancer, which is crucial for developing personalized treatment plans.

What evidence suggests that transbronchial cryobiopsy is effective for lung cancer diagnosis?

Research has shown that transbronchial cryobiopsy (TBCB), which participants in this trial will undergo, is a promising method for diagnosing lung cancer. Studies have found it safe and effective, particularly for older patients, as it provides better samples for detailed testing. One study showed that TBCB improved the diagnosis rate by 8.6% compared to traditional methods. It also has a good safety record, making it a reliable choice. This evidence suggests that TBCB could serve as a helpful alternative to standard biopsy techniques. ^{1 2 3 6 7}

Who Is on the Research Team?

Or Kalchiem-Dekel, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 (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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39725905/

Safety and efficacy of transbronchial cryobiopsy for elderly ... TBLC was found to be a safe and effective diagnostic tool for peripheral lung cancer in elderly patients and provided adequate samples for molecular testing.

2. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-024-03456-1

Safety and efficacy of transbronchial cryobiopsy for elderly ... TBLC was found to be a safe and effective diagnostic tool for peripheral lung cancer in elderly patients and provided adequate samples for molecular testing.

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. publications.ersnet.org publications.ersnet.org/content/erj/62/suppl67/pa4627

Safety and cost-effectiveness of transbronchial lung ... Conclusion: The pre-placement of a balloon in TBLC for diagnosing ILD may not deal with severe bleeding and will cost patients more. Preparing a balloon with a ...

5. journal.chestnet.org journal.chestnet.org/article/S0012-3692(21)00885-0/abstract

Safety and Performance of Transbronchial Cryobiopsy for ... TLCB showed an acceptable safety profile and diagnostic yield for the evaluation of PPL in this large retrospective cohort. Prospective clinical ...

6. publications.ersnet.org publications.ersnet.org/content/erj/50/suppl61/pa3020

Diagnostic yield and safety of transbronchial lung cryobiopsy ... Conclusion: In our cohort, TBLC provided a better diagnostic yield than FTBB without increasing the risk of adverse events such as bleeding and pneumothorax.

7. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.840702/full

Efficacy and Safety of Cryobiopsy vs. Forceps Biopsy for ... Our results demonstrate that cryobiopsy is a safe and efficacious alternative to conventional forceps biopsy.