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Official title Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain
ClinicalTrials.gov ID: NCT07636382
What this study is testing
- What it's testing
- 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.
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
- people must have histologically or cytologically confirmed cancer that is metastatic or unresectable, and considered appropriate per the treating...
- Age \>18 years. Because no data are currently available on the use of celiac axis SBRT in people ≤18 years of age, children are excluded from this...
- 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...
- people must have anatomical involvement of the celiac plexus on the diagnostic CT, PET/CT, or MRI. This includes: Any pancreatic cancer, any other...
You likely can't join if
- 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.
- people 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...
See the full eligibility criteria
- people 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 people ≤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.
- people 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...
- 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.
- people must have the ability to understand and the willingness to sign a written informed consent document.
- people must have a diagnostic CT of the abdomen and pelvis, with or without contrast, acquired \< 28 days prior to the study consent.
- 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.
- people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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 Toronto, Ontario, Canada. 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.