What side effects are associated with this type of intervention?

Common treatments for lung diseases that involve bronchoscopic interventions and cryotherapy, such as the 1.1mm cryoprobe for transbronchial biopsy, can have several side effects. These include acute bronchial inflammation, bleeding, mucosal injury, and edema. Cryotherapy specifically can lead to acute pulmonary hemorrhage and edema, which may progress to fibrosis over time. Additionally, there is a risk of infection and scarring in the treated lung segments. These side effects are generally related to the direct collateral injury caused by the freezing process.

What prior FDA approvals exist?

FDA approvals for lung disease treatments have included various drugs and techniques. For instance, atezolizumab and durvalumab, both anti-PD-L1 antibodies, have been approved for non-small cell lung cancer (NSCLC). Cemiplimab, a PD-1 inhibitor, has also been approved for advanced NSCLC with high PD-L1 expression. While these approvals focus on immunotherapy, techniques like the 1.1mm cryoprobe for transbronchial biopsy are used diagnostically rather than therapeutically. The cryoprobe method, which involves freezing tissue to obtain a biopsy sample, is a diagnostic tool rather than a treatment modality.

What other types of research exist?

Promising, novel alternatives for lung disease treatment in 2024 include stereotactic body radiation therapy (SBRT) and radiofrequency ablation (RFA). These methods are advanced and have shown efficacy in treating lung cancer, potentially offering less invasive options compared to traditional biopsy techniques.

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Procedure

Cryobiopsy vs Forceps Biopsy for Lung Disease (FROSTBITE-2 Trial)

N/A

Waitlist Available

Led By Jeffrey Thiboutot, MD, MHS

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Presence of bleeding disorder

Severe pulmonary hypertension (RVSP > 60 mmHg)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days of procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a new method to a standard one for lung biopsies. It targets patients needing lung tissue samples, aiming to improve sample quality and reduce complications. The new method works by freezing and removing tissue, providing larger and higher-quality samples with a good safety and cost-benefit profile.

Who is the study for?

This trial is for adults over 18 who need a lung biopsy as part of their usual care. It's not for those with bleeding disorders, severe heart or lung conditions, recent strokes or heart attacks, low platelet counts, or women who could be pregnant and won't test. People on certain blood thinners can't join.

What is being tested?

The study is testing if using a smaller cryoprobe (1.1mm) to take lung tissue samples is as effective as the standard larger forceps (2.0mm). Participants will undergo bronchoscopy where either the cryoprobe or forceps will be used for biopsy.

What are the potential side effects?

Possible side effects include bleeding at the biopsy site, pain or discomfort from the procedure, risk of infection post-biopsy, and potential complications related to bronchoscopy such as reaction to anesthesia.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a bleeding disorder.

Select...

I have severe high blood pressure in the lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days of procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days of procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnostic yield as assessed by number of patients for which the procedure led to a diagnosis

Secondary study objectives

Activation Time

Adequacy for Molecular Testing

Alveolated Area

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CryoprobeExperimental Treatment1 Intervention

Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe

Group II: ForcepsActive Control1 Intervention

Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651

2020

N/A

~60

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung disease often aim to reduce inflammation, manage infections, and improve respiratory function. For instance, cryoprobes are used in transbronchial biopsies to freeze and obtain tissue samples, which helps in diagnosing and tailoring specific treatments. Glucocorticoids, such as prednisone, reduce inflammation and immune response, crucial for conditions like idiopathic pulmonary fibrosis and nonspecific interstitial pneumonia. Broad-spectrum antibiotics are used to treat or prevent infections, which are common complications in lung disease patients. Supportive measures, including supplemental oxygen, help alleviate symptoms and improve quality of life. These treatments are vital as they address the underlying causes and symptoms, thereby improving patient outcomes and quality of life.

Administration of Drugs/Gene Products to the Respiratory System: A Historical Perspective of the Use of Inert Liquids.Identification of potential genes in endobronchial tuberculosis after bronchoscopic cryotherapy by transcriptome sequencing.The Role of miR-497/EIF3A Axis in TGFβ1-Induced Epithelial-Mesenchymal Transition and Extracellular Matrix in Rat Alveolar Epithelial Cells and Pulmonary Fibroblasts.