Cryobiopsy vs Core Needle Biopsy for Lymph Node Cancer
(COLD SNAP Trial)
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.12345Why 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.12467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo FNA followed by either core needle biopsy or cryobiopsy
Follow-up
Participants are monitored for safety and effectiveness after biopsy procedures
What Are the Treatments Tested in This Trial?
Interventions
- Core Needle Biopsy
- Cryobiopsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
San Antonio Uniformed Services Health Education Consortium
Lead Sponsor