SarcomaPhase 4NCT04033081
Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®
A Phase 4 study testing CivaSheet in people with Sarcoma, run by CivaTech Oncology at 1 site in United States.
Trial summary
This patient study will determine the safety and toxicity of a permanently implantable brachytherapy source - CivaSheet® - which is designed to deliver a therapeutic dose of low dose rate (LDR) radiation with polymer encased Palladium-103. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- CivaSheet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2020to Apr 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject Signed Inform Consent
- Subject plans to remain in the long-term care of his/her enrolling center/investigators.
- Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate.
- Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk
- Subject is able to undergo surgery
Who cannot join
- Is unable or unwilling to comply with protocol requirements.
- Is enrolled in another study/registry not approved by CivaTech Oncology.
- Pregnancy, breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Registry of Retroperitoneal, Abdominal, Pelvic and Truncal Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet® to Evaluate the Safety and Feasibility Over 5 Years
This patient study will determine the safety and toxicity of a permanently implantable brachytherapy source - CivaSheet® - which is designed to deliver a therapeutic dose of low dose rate (LDR) radiation with polymer encased Palladium-103. CivaSheet will be implanted in sarcoma patients with disease presenting in the retroperitoneum, abdomen, pelvis and trunk.
Read the detailed description
CivaSheet® is an FDA-cleared product from CivaTech Oncology®. It is a series of small radioactive palladium-103 (Pd-103) sources on bio-absorbable, flexible, bio-compatible membrane. The CivaSheet can be custom cut in the operating room. The CivaSheet is 5 cm wide by 15 cm long and has a rim to allow an easy surface to suture. This flexible device can contour the surgical cavity delivering highly conformal and targeted radiation dose. CivaSheet can deliver a very high radiation dose to the surgical margin to potential prevent local cancer recurrence.
Sarcoma patients have up to 80% local recurrence rates, depending on histology and location of disease presentation. CivaSheet will be implanted at the surgical margin follow tumor removal. Monitoring the rate of acute toxicity is the primary endpoint. Secondary endpoints include disease progression and recurrence rates.
- Conditions
- Sarcoma
- Being tested
- CivaSheet
- Keywords
- CivaSheet, IORT, Intraoperative Radiation Therapy, Brachytherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CivaSheetDevice
Also called brachytherapy, Intraoperative Radiation Therapy
Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence
| Study group | Role | What they receive |
|---|---|---|
| CivaSheet Treatment | Experimental | Implanted with CivaSheet during tumor removal Receives: Device: CivaSheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of acute toxicity
rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria
Measured: 90 days post implant
Secondary outcomes (4)
Local control rate
rate of local tumor recurrences
Measured: 5 years
Reoperation rate
Rate of re-operation for any reason
Measured: 5 years
Complication rate
Rate of complications following device implant related or unrelated to the device
Measured: 6 months
Dose to target and OAR
Amount of radiation dose delivered to the target volume and the adjacent organs at risk
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start30 Apr 2020
- Primary completionJan 2027 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CivaTech Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dian Wang, MD, Principal investigator, Rush University Medical CenterKrisha Howell, MD, Principal investigator, Michigan Healthcare Professionals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033081
- Sponsor's protocol ID
- CT007
- Status last verified
- Mar 2026
- First submitted
- 23 Jul 2019
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Retroperitoneal, Abdominal, Pelvic and Truncal Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet® to Evaluate the Safety and Feasibility Over 5 Years
- ClinicalTrials.gov ID
- NCT04033081
- Acronym / sponsor ID
- CT007
- Conditions
- Sarcoma
- Keywords
- CivaSheet, IORT, Intraoperative Radiation Therapy, Brachytherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CivaTech OncologyIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This patient study will determine the safety and toxicity of a permanently implantable brachytherapy source - CivaSheet® - which is designed to deliver a therapeutic dose of low dose rate (LDR) radiation with polymer encased Palladium-103. CivaSheet will be implanted in sarcoma patients with disease presenting in the retroperitoneum, abdomen, pelvis and trunk.
Detailed description
CivaSheet® is an FDA-cleared product from CivaTech Oncology®. It is a series of small radioactive palladium-103 (Pd-103) sources on bio-absorbable, flexible, bio-compatible membrane. The CivaSheet can be custom cut in the operating room. The CivaSheet is 5 cm wide by 15 cm long and has a rim to allow an easy surface to suture. This flexible device can contour the surgical cavity delivering highly conformal and targeted radiation dose. CivaSheet can deliver a very high radiation dose to the surgical margin to potential prevent local cancer recurrence.
Sarcoma patients have up to 80% local recurrence rates, depending on histology and location of disease presentation. CivaSheet will be implanted at the surgical margin follow tumor removal. Monitoring the rate of acute toxicity is the primary endpoint. Secondary endpoints include disease progression and recurrence rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CivaSheet Treatment | Experimental | Device: CivaSheetImplanted with CivaSheet during tumor removal |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subject Signed Inform Consent
- Subject plans to remain in the long-term care of his/her enrolling center/investigators.
- Sarcoma evident on imaging. Pathology biopsy proven or suspected by imaging but not a biopsy candidate.
- Sarcoma in the retroperitoneum, abdomen, pelvis, or trunk
- Subject is able to undergo surgery
Key exclusion criteria (3 listed)
- Is unable or unwilling to comply with protocol requirements.
- Is enrolled in another study/registry not approved by CivaTech Oncology.
- Pregnancy, breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CivaSheetAlso: brachytherapy, Intraoperative Radiation TherapyImplanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence | Device | CivaSheet Treatment |
Primary outcome
Rate of acute toxicity
Time frame: 90 days post implant
rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria
4 secondary outcomes
Local control rate
Time frame: 5 years
Reoperation rate
Time frame: 5 years
Complication rate
Time frame: 6 months
Dose to target and OAR
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dian Wang, MD principal investigator
Rush University Medical Center
Krisha Howell, MD principal investigator
Michigan Healthcare Professionals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CivaSheet in people with Sarcoma, run by CivaTech Oncology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acute toxicity (time frame: 90 days post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.