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Simulation-Free Celiac Plexus Pain Ablation Using SBRT for Cancer-Related Pain

This study is for people experiencing severe abdominal pain due to pancreatic cancer. Doctors often use radiation therapy called stereotactic body radiotherapy (SBRT) to help with this pain. Preparing for SBRT usually takes a week or more. This study is testing a new, faster way to plan and deliver SBRT, called a "simulation-free workflow." Instead of new scans, this workflow uses your existing diagnostic images (CTs, PET/CTs, or MRIs) to create your treatment plan. The goal is to see if this faster method is practical and meets safety standards for delivering radiation. You may be eligible if you have confirmed cancer that is metastatic or unresectable and are over 18 years old. This study plans to enroll 5 participants.

Study design
This is an interventional study, not specifying a phase, and plans to enroll 5 participants.
What's involved
You would receive SBRT treatment, which will take up to 1.5 hours. Pre-existing diagnostic images will be used for treatment planning.
Compensation
Not stated in the trial record.
Follow-up
The primary goals of the study are measured at the time of the treatment visit, which is 1.5 hours.

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NCT07117032

Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy (SBRT) in Participants With Cancer-Related Celiac Pain

Recruiting
PHASE1Ages 18+InterventionalTreatment
Case Comprehensive Cancer Center
~5 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Simulation-free workflowCeliac plexus SBRT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of the simulation-free adaptive radiotherapy workflow, as measured by rate of successful completion of treatment
Measured over At treatment visit, 1.5 hours
+1 more outcome measured

Conditions

Pancreatic Cancer
Retroperitoneal Pain Syndrome

Explore related trials

Pancreatic CarcinomaSolid Neoplasm

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Lauren Henke, MD, MSCI · PRINCIPAL_INVESTIGATOR · Case Comprehensive Cancer Center, University Hospitals

Who to contact

Lauren Henke, MD, MSCI
[email protected]
(218) 234 -6429
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Eligibility criteria

Inclusion

Participants must have histologically or cytologically confirmed cancer that is metastatic or unresectable, and considered appropriate per the treating physician to receive celiac plexus SBRT.
Age \>18 years. Because no data are currently available on the use of celiac axis SBRT in participants ≤18 years of age, children are excluded from this study.
Performance status: ECOG Performance status ≤ 3
Severe retroperitoneal pain syndrome (radiates from the lower back to the upper abdomen, belt- like distribution), intensity of at least 5 on 11-point Brief Pain Inventory (BPI, average pain) scale despite analgesic use. Note: previous use of celiac plexus block/neurolysis for pain control is allowed and will be recorded
Participants must have anatomical involvement of the celiac plexus on the diagnostic CT, PET/CT, or MRI. This includes:
Any pancreatic cancer
Any other cancer that on imaging demonstrates either gross involvement of the celiac blood vessels or celiac plexus on imaging OR haziness around the celiac blood vessels that typically implies tumor engulfment.
Prior chemotherapy or biological treatment is allowed, but any active oncological treatment must be stopped at least 1 week prior to radiation therapy and renewed at least 1 week following radiation therapy.
Participants must have the ability to understand and the willingness to sign a written informed consent document.
Participants must have a diagnostic CT, PET/CT, or MRI of the abdomen and pelvis, with or without contrast, acquired \< 28 days prior to the study consent. This diagnostic scan, to be used for pre-plan formation, must fully visualize the celiac plexus target intended for simulation-free treatment, with full axial field-of-view at the axial levels for treatment. The scan must be of sufficient clinical quality for the treating physician to delineate the target for treatment.

Exclusion

Prior radiotherapy to the upper abdomen.
Previous radiotherapy to the upper abdomen overlapping with the projected site of treatment.
Pregnant or breastfeeding women are excluded from this study.
Participants with conditions associated with increased risk of side effects from radiation such as inflammatory bowel disease and scleroderma.
Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol principal investigator, documentation of this exception is sufficient in lieu of a pregnancy test.

What this trial measures

  • Feasibility of the simulation-free adaptive radiotherapy workflow, as measured by rate of successful completion of treatmentAt treatment visit, 1.5 hours

    Successful completion is defined as completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of participants with simulation-free plans meeting dosimetric requirements.

  • Feasibility of the simulation-free adaptive radiotherapy workflow, as measured by rate of compliance with priority level 1 dose constraintsAt treatment visit, 1.5 hours

    Compliance with priority level 1 dose constraints is defined as having a pre-treatment quality assurance clinical gamma passing index less than or equal to 2%/ 2mm.