Cryobiopsy vs Core Needle Biopsy for Lymph Node Cancer

(COLD SNAP Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Antonio Uniformed Services Health Education Consortium

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Severe allergies, Overlying infection, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two biopsy methods for detecting cancer in lymph nodes: the standard core needle biopsy and cryobiopsy, which uses extreme cold to collect tissue samples. Researchers aim to determine which method more effectively diagnoses cancer when suspected in the lymph nodes. Suitable participants have had a scan, such as a CT or ultrasound, indicating possible cancer in their lymph nodes and require additional tissue samples for diagnosis or staging. The trial is not suitable for individuals with allergies to certain local anesthetics or those taking specific blood thinners. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance diagnostic methods for future patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but if you are on anticoagulation or anti-platelet therapy (medications that prevent blood clots), you may need to stop them unless it's aspirin alone. This will be determined by your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cryobiopsy is generally safe for diagnosing lymph node issues. Studies indicate it has a good safety record. It has been used to diagnose chest area problems, with reports highlighting its effectiveness and safety. These studies have noted no major safety concerns, suggesting it is well-tolerated.

Cryobiopsy involves freezing a small piece of tissue to obtain a sample, aiding in clearer diagnosis. In contrast, a core needle biopsy, a more traditional method, uses a larger needle to remove tissue. Both methods aim to minimize risks. However, like any procedure, there is always a small risk of bleeding or infection, though these risks are generally low.

In summary, both cryobiopsy and core needle biopsy have been used safely in similar situations. Participants considering a trial involving these procedures can be reassured by evidence of safety from previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares cryobiopsy to the traditional core needle biopsy for diagnosing lymph node cancer. Unlike the standard core needle biopsy, which uses a needle to remove a tissue sample, cryobiopsy involves freezing a small area of tissue to obtain a sample. This method can potentially provide larger, more intact samples, which might improve diagnostic accuracy. By evaluating these two techniques, researchers aim to determine if cryobiopsy can enhance diagnostic precision, potentially leading to better treatment decisions for patients.

What evidence suggests that this trial's treatments could be effective for lymph node cancer?

In this trial, participants will join one of two arms to compare biopsy methods for diagnosing lymph node cancers. The Experimental Arm will use cryobiopsy, which previous studies have shown to have a higher success rate than traditional methods. For instance, some studies found that cryobiopsy identified both cancerous and non-cancerous growths in up to 91.7% of cases, outperforming some standard techniques. This suggests cryobiopsy might be more effective in detecting cancerous nodes. Additionally, it carries fewer risks, making it a safer procedure. Meanwhile, the Control Arm will use the Core Needle Biopsy method. These findings suggest cryobiopsy could be a more reliable option for diagnosing lymph node cancer. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-89 with suspected or confirmed cancer and signs of cancer in peripheral lymph nodes as shown by imaging tests. It's not for those under 18 or over 89, on certain blood thinners that can't be stopped safely, if the node can't be reached for biopsy, if they prefer not to participate, have severe allergies to local anesthetics or antiseptics used during the procedure, have an infection at the biopsy site, or other safety concerns.

Inclusion Criteria

My scans suggest cancer may have spread to my lymph nodes, needing further tests.

Exclusion Criteria

Inability to reach the lymph node through a core needle introducer sheath as determined by the performing physician.

I am on blood thinners that can't be stopped safely, except for aspirin.

I prefer this treatment option.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo FNA followed by either core needle biopsy or cryobiopsy

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after biopsy procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Core Needle Biopsy
• Cryobiopsy

Trial Overview

The study is testing cryobiopsy against standard core needle biopsy in patients with suspected malignant lymph nodes. Cryobiopsy uses extreme cold to obtain tissue samples while core needle biopsy uses a sharp instrument. The goal is to see which method might provide better diagnostic information.

How Is the Trial Designed?

Group I: Experimental Arm Experimental Treatment 1 Intervention

FNA followed by cryobiopsy through a introducer sheath

Group II: Control Arm Active Control 1 Intervention

FNA followed by Core Needle biopsy

Who Is Running the Clinical Trial?

San Antonio Uniformed Services Health Education Consortium

Lead Sponsor

Trials

6

Recruited

900+

Published Research Related to This Trial

Transbronchial cryobiopsy (TBCB) was successfully performed on 35 patients with suspicious mediastinal lesions, showing high diagnostic accuracy with a sensitivity of 93.3% and specificity of 100%.

The procedure had a low complication rate, with only one case of pneumomediastinum that did not require further treatment, indicating that TBCB is a safe and effective method for diagnosing mediastinal neoplasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transbronchial cryobiopsy for mediastinal lesions: a pilot study]. Danilevskaya, OV., Chernikova, EN., Esakov, YS., et al.[2023]

Cryobiopsy of mediastinal lymph nodes (cryoEBUS) demonstrated a higher diagnostic yield compared to conventional EBUS-TBNA, with an overall effectiveness of 92% versus 80%, particularly excelling in diagnosing lymphomas and benign conditions.

The procedure allows for better characterization of lymphoma subtypes and enables genetic studies in 97% of samples, while maintaining a safety profile with no serious complications reported, although light bleeding occurred in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the diagnostic yield of mediastinal lymph node cryobiopsy (cryoEBUS) better for diagnosing mediastinal node involvement compared to endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)? A systematic review. Botana-Rial, M., Lojo-Rodríguez, I., Leiro-Fernández, V., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11982995/

Mediastinal lymph node cryobiopsy guided by ...

Compared to a yield by EBUS-TNBA of 53.2% for benign lesions and 25.0% for non-lung cancer tumors, the EBUS-TBC yield was 80.9% and 91.7%, ...

2.

amj.amegroups.org

amj.amegroups.org/article/view/9530/html

Transbronchial mediastinal cryobiopsy—literature review and ...

Our literature review, comprising of 20 published articles, highlights the efficacy EBUS-TBMC for evaluation of both malignant and benign mediastinal lesions.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0954611123002779

Is the diagnostic yield of mediastinal lymph node ...

Although cryoEBUS did not significantly improve the diagnosis of lung cancer compared to EBUS-TBNA, the results were significantly better in patients with ...

4.

bmjopenrespres.bmj.com

bmjopenrespres.bmj.com/content/11/1/e002617

Ultrasound-guided transbronchial cryobiopsy of ...

Cryobiopsy of mediastinal and hilar lesions improves the diagnostic yield compared with EBUS-TBNA while maintaining a favourable safety profile.

5.

nature.com

nature.com/articles/s41598-024-69702-y

An explorative analysis on the optimal cryo-passes and ...

This study aims to determine the optimal number of cryo-passes and freezing time of the ultrathin cryoprobe in EBUS-TBMC concerning specimen size and ...

6.

resmedjournal.com

resmedjournal.com/article/S0954-6111(25)00357-9/fulltext

Diagnostic performance and safety of endobronchial ...

Endobronchial ultrasound-guided transbronchial cryobiopsy (Cryo-EBUS) is an emerging technique for diagnosing mediastinal lesions, offering larger and ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0169500225005288

Application of endobronchial ultrasound-guided cryobiopsy ...

Recently, the utility of endobronchial ultrasound-guided cryobiopsy (EBUS-cryo) in the diagnosis of mediastinal lymph node lesions has been reported [6,7]. This ...