Cryoneurolysis for Cancer-related Pelvic Pain

SJ
MR
Overseen ByMelissa Ruiz
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Arizona
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if two different treatments can alleviate severe, ongoing pelvic pain caused by cancer. The first treatment uses a CT scan to guide the freezing of specific nerves that transmit pain signals, while the second treatment employs cold temperatures to numb these nerves. The trial will monitor patients who try the first treatment and, if necessary, the second one, to evaluate effectiveness and identify any side effects. Potential participants are those with cancer-related pelvic pain unrelieved by current treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from innovative pain relief methods.

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

The trial information does not specify if you need to stop taking your current medications. It seems that the study will not alter your standard care, so you may be able to continue your current medications, but it's best to confirm with the study team.

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

Research has shown that using a CT scan to guide pudendal nerve cryoneurolysis is generally safe for managing pain. One study found this treatment both safe and effective for various pain conditions. Another report indicated a low risk of complications when doctors use imaging to accurately target the nerves.

While more research is needed to determine the duration of pain relief and fully understand long-term safety, current evidence suggests the procedure is usually well-tolerated. These findings offer reassurance to those concerned about safety.12345

Why are researchers excited about this trial?

Researchers are excited about CT-guided pudendal nerve cryoneurolysis because it offers a new approach to easing malignancy-induced pelvic pain. Unlike traditional pain management options like medication or nerve blocks, this technique uses cryoneurolysis to freeze and disrupt the nerve pathways transmitting pain signals. This method aims to provide longer-lasting relief with potentially fewer side effects than pharmacological treatments. Additionally, the use of CT guidance allows for precise targeting of the pudendal nerve, potentially improving the effectiveness of pain control.

What evidence suggests that these treatments could be effective for cancer-related pelvic pain?

Research has shown that using CT scans to guide pudendal nerve cryoneurolysis, a procedure participants in this trial may receive, can help manage pelvic pain caused by cancer. This treatment freezes the nerves that send pain signals, significantly reducing pain. Studies have found that this method offers longer-lasting pain relief compared to injections or catheters. It also carries a lower risk of complications, making it a safer choice for many patients. Advanced imaging accurately targets the nerves, enhancing the treatment's effectiveness.12367

Who Is on the Research Team?

SJ

Shamar J Young, MD

Principal Investigator

University of Arizona - Department of Medical Imaging

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

CT-guided bilateral pudendal nerve cryoneurolysis

Participants undergo CT-guided bilateral pudendal nerve cryoneurolysis to target and freeze the pudendal nerves for pain relief

4-6 weeks
1 visit (in-person)

Percutaneous image-guided cryoneurolysis

If the first treatment is not effective, participants undergo percutaneous image-guided cryoneurolysis using extremely cold temperatures to alleviate pain

4-6 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CT-guided Pudendal Nerve Cryoneurolysis
  • Percutaneous image-guided cryoneurolysis

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Cohort 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials
545
Recruited
161,000+

Citations

Percutaneous Image-Guided Cryoneurolysis | AJR

Percutaneous image-guided cryoneurolysis is safe and effective for the management of several well-described syndromes involving neuropathic pain.

Percutaneous Image-guided Cryoneurolysis

Interventional cryoneurolysis is the clinical expansion of nerve targeting with advanced imaging guidance to induce a specific cold-mediated injury.

TRANSFORMING PAIN TREATMENTS

Outcomes measured include distances from the ablation sites to origins of distal musculature, times to initial clinical recovery and muscle activation, and rate ...

Percutaneous cryoanalgesia for pain palliation

Cryoanalgesia is a safe procedure with minimal risk of complications when performed with percutaneous approaches under imaging guidance.

New study cites a possible breakthrough treatment in pain ...

CT-guided cryoneurolysis uses imaging to place a needle and freeze damaged nerves, causing them to degenerate and lose function. "What happens ...

Percutaneous Image-Guided Cryoneurolysis

Several groups have recent- ly described safe approaches using image guidance to target precise segments of the greater occipital nerve for injection of ...

Insights from a 328-Patient Cohort across 12 Years

CT-guided percutaneous cryoneurolysis of pudendal nerve is feasible and safe. Future work is required to document the durability and long-term safety of ...