NCT07117032 Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy (SBRT) in Participants With Cancer-Related Celiac Pain
| NCT ID | NCT07117032 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Case Comprehensive Cancer Center |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 5 participants in total. It began in 2026-05-12 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Participants who are experiencing abdominal pain due to having cancer in their pancreas may be eligible for this research study. For this type of pain, doctors often recommend radiation therapy to help with the pain. This radiation therapy is called stereotactic body radiotherapy (SBRT). Preparing for SBRT typically takes a week or longer. In this research study, doctors want to test a new workflow in order to shorten the time it takes for participants to receive SBRT to help with their pain. Doctors typically determine how to administer the SBRT by doing a simulation, which requires a CT (Computerized Tomography) scan. The CT scan is used to create a treatment plan. It can take time to schedule this CT scan and then it takes 5-10 days to create a treatment plan. A way to reduce the planning time for SBRT is to use the CT scan that participants had when their cancer was diagnosed to plan the SBRT. This new workflow can cut down the time it takes to schedule another CT scan and plan for and deliver SBRT. The workflow where doctors use a pre-existing CT scan is called CTsim-free treatment planning. CTsim-free treatment planning is what is being tested in this research study.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Lauren Henke, MD, MSCI
PRINCIPAL INVESTIGATOR
Case Comprehensive Cancer Center, University Hospitals
Frequently Asked Questions
Who can join the NCT07117032 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07117032 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07117032 currently recruiting?
Yes, NCT07117032 is actively recruiting participants. Contact the research team at lauren.henke@uhhospitals.org for enrollment information.
Where is the NCT07117032 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07117032 clinical trial?
NCT07117032 is sponsored by Case Comprehensive Cancer Center. The principal investigator is Lauren Henke, MD, MSCI at Case Comprehensive Cancer Center, University Hospitals. The trial plans to enroll 5 participants.
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