Registry of Sarcoma Patients Treated With Permanently Imp... | NCT04033081

Studies
Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®

NCT04033081

Sponsor

CivaTech Oncology

Status

Active, not recruiting

Last Update Posted

Mar 23, 2026Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Sarcoma

Interventions

CivaSheet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2020Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Apr 2030Estimated

First Submitted Date

Jul 23, 2019

First Submission Date that Met QC Criteria

Jul 23, 2019

First Posted Date

Jul 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2026

Last Update Posted Date

Mar 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CivaSheet Treatment	Experimental	Implanted with CivaSheet during tumor removal	Device: CivaSheet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CivaSheet	Device	Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence	CivaSheet Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of acute toxicity	rate of greater than or equal to Grade 3 toxicity events based on CTCAE criteria	90 days post implant

Secondary Outcomes

Measure	Description	Time Frame
Local control rate	rate of local tumor recurrences	5 years
Reoperation rate	Rate of re-operation for any reason	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Is unable or unwilling to comply with protocol requirements.
Is enrolled in another study/registry not approved by CivaTech Oncology.
Pregnancy, breast feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dian Wang, MD	Rush University Medical Center	Principal Investigator
Krisha Howell, MD	Michigan Healthcare Professionals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fox Chase Cancer Center		Philadelphia	Pennsylvania	19111	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001918	Brachytherapy

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided