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New treatment option for Thoracoabdominal Wall Pain
Official title A Study of Stereotactic Radiosurgery (SRS) to Treat Pain in the Chest and/or Stomach Wall
ClinicalTrials.gov ID: NCT05985148
What this study is testing
- What it's testing
- The researchers are doing this study to find out whether stereotactic radiosurgery (SRS) is a safe, practical (feasible), and effective treatment for people with chronic TAWP. The researchers will test different doses of SRS to find the highest dose that causes few or mild side effects.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have a documented history of chronic (≥ 3 months) thoracoabdominal wall pain (TAWP) attributable to ≤ 3 unilateral spinal levels as...
- Patients must have TAWP that is inadequately relieved by a trial of conventional pharmacologic therapy (defined as NRS pain score ≥ 4/10 while on...
- KPS ≥ 60%
- Age ≥ 18 years old
You likely can't join if
- Patients with a life expectancy of \< 6 months as predicted by the Adult Comorbidity Index (ACE-27, see Appendix 1)
- Patients with active autoimmune connective tissue disease
- Patients with bilateral TAWP
- Patients with preexisting pneumothorax
- Patients with preexisting excessive pleural effusion (extending \> 3 vertebral levels)
- Systemic chemotherapy delivered or planned to be delivered within +/- 5 days of SRS
See the full eligibility criteria
- Patients must have a documented history of chronic (≥ 3 months) thoracoabdominal wall pain (TAWP) attributable to ≤ 3 unilateral spinal levels as confirmed by diagnostic paravertebral nerve block or TENS (if results of...
- Patients must have TAWP that is inadequately relieved by a trial of conventional pharmacologic therapy (defined as NRS pain score ≥ 4/10 while on treatment with conventional pharmacologic therapy for analgesia) as...
- KPS ≥ 60%
- Age ≥ 18 years old
- Patients with a life expectancy of \< 6 months as predicted by the Adult Comorbidity Index (ACE-27, see Appendix 1)
- Patients with active autoimmune connective tissue disease
- Patients with bilateral TAWP
- Patients with preexisting pneumothorax
- Patients with preexisting excessive pleural effusion (extending \> 3 vertebral levels)
- Systemic chemotherapy delivered or planned to be delivered within +/- 5 days of SRS
- Unable to undergo a diagnostic paravertebral nerve block
- Unable to undergo at least one of either a myelogram or spine MRI
- Patients for whom external beam treatment plans to deliver the prescription SRS dose to the lesion of interest cannot be safely designed as specified by the Dose Constraint Guidelines in Appendix 2
- Evaluation of any radiation doses previously delivered to spinal cord/cauda equina and other critical structures (bowel, esophagus, lungs, kidneys, rectum) will be taken into consideration
- If radiation dose from SRS would exceed any normal tissue constraint as noted in Appendix 2, the patient will be ineligible
- Abnormal complete blood count. Any of the following:
- Platelet count \< 75 K/µL
- Hgb level \< 9 g/dl
- WBC \< 3.5 K/µl
- Abnormal coagulation profile: INR \> 2.5 INR and/or APTT \> 80 seconds. Patients who are on anticoagulation medication that may not be safely held for the myelogram procedure (≥ 5 days for antiplatelet agents and...
- Allergy to local anesthestics
- Local infection at the site of injection of anesthetic
- Severe spinal deformities with anatomic distortion (severe scoliosis/kyphoscoliosis)
- Severe respiratory disease (i.e. oxygen dependent)
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.