New radiation patch implanted during surgery aims to stop sarcoma from coming back
NCT ID NCT04033081
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a device called CivaSheet, a permanent radiation patch placed inside the body during surgery to kill any remaining sarcoma cells. About 100 people with sarcoma in the abdomen, pelvis, or trunk will be followed for 5 years to see how safe it is and whether it helps prevent the cancer from returning. The main focus is on serious side effects and how well the radiation targets the right area.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CivaSheet (a permanent radiation implant placed during surgery to target leftover cancer cells)
- What this could lead to
- If successful, this could provide a new way to reduce sarcoma recurrence after surgery by delivering targeted radiation directly to the tumor bed.
- What could go wrong
- This is a single-arm registry, not a randomized trial, so it cannot prove the device is better than standard care. Risks include radiation-related side effects and the need for additional surgeries.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2020
- Expected to finish
-
Apr 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject Signed Inform Consent 2. Subject plans to remain in the long-term care of his/her enrolling center/investigators. 3. Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate. 4. Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk 5. Subject is able to undergo surgery Exclusion Criteria: 1. Is unable or unwilling to comply with protocol requirements. 2. Is enrolled in another study/registry not approved by CivaTech Oncology. 3. Pregnancy, breast feeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Blood-Flow-Blocking drug stall a rare sarcoma?
- Can a new drug shrink advanced solid tumors?
- Can a coordinated care team reduce severe side effects in older cancer patients?
- Can repeated MRI scans reveal how tumors respond to radiation?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?
- Pedaling through chemo: could exercise boost tumor blood flow?