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

490 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Cryobiopsy vs Core Needle Biopsy for Lymph Node Cancer?

Research suggests that cryobiopsy, a technique that collects larger tissue samples, may improve the ability to diagnose certain lymph node conditions compared to traditional methods like EBUS-TBNA (a type of needle biopsy). This could be particularly useful for diagnosing rare tumors and diseases where more tissue is needed for accurate analysis. ^{1 2 3 4 5}

How does cryobiopsy differ from other treatments for lymph node cancer?

Cryobiopsy is unique because it uses a cooling technique to collect larger tissue samples from lymph nodes, which can improve diagnostic accuracy compared to traditional needle aspiration methods that often provide smaller samples. ^{1 2 3 4 5}

What is the purpose of this trial?

Cryobiopsy of peripheral lymph nodes with suspected malignant potential with comparison to standard core needle biopsy.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Mediastinal Nodular Lymphocyte Predominant Hodgkin Lymphoma Achieved by Endoscopic Transesophageal Cryobiopsy. [2022]

3. Singapore pubmed.ncbi.nlm.nih.gov

Mediastinal "deep freeze"-transcarinal lymph node cryobiopsy. [2023]

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

Optimizing the endoscopic diagnosis of mediastinal lymphadenopathy: a glimpse on cryobiopsy. [2022]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Transbronchial cryobiopsy for mediastinal lesions: a pilot study]. [2023]