NCT07636382 Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain
| NCT ID | NCT07636382 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Advanced Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-06-01 |
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.
This trial targets 5 participants in total. It began in 2026-06-01 with a primary completion date of 2027-06-01.
⚠ 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
This is a prospective, single-arm, pilot feasibility clinical trial designed to evaluate the feasibility and safety of a simulation-free adaptive radiotherapy workflow to enable single-session celiac plexus SBRT planning and delivery. In this trial, the treatment itself is non-investigational (standard-of-care celiac plexus SBRT) but the treatment workflow (simulation-free, using adaptive radiotherapy to compress treatment planning and delivery into a single session) is novel. Investigators hypothesize the successful completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of patients.
Eligibility Criteria
Inclusion Criteria: * Subjects 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 subjects ≤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. * Subjects 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 should be stopped at least 1 week prior to radiation therapy and renewed at least 1 week following radiation therapy. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. * Subjects must have a diagnostic CT of the abdomen and pelvis, with or without contrast, acquired \< 28 days prior to the study consent. Exclusion Criteria: * In ability to tolerate lying supine and still for at least 45 minutes. * Performance status: ECOG Performance status of 4. * Previous radiotherapy to the upper abdomen overlapping with the projected site of treatment. * Pregnant or breastfeeding women are excluded from this study. * Subjects 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
Frequently Asked Questions
Who can join the NCT07636382 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07636382 currently recruiting?
Yes, NCT07636382 is actively recruiting participants. Contact the research team at michael.yan@uhn.ca for enrollment information.
Where is the NCT07636382 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07636382 clinical trial?
NCT07636382 is sponsored by University Health Network, Toronto. The trial plans to enroll 5 participants.
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