Evaluation of Tumor Resection Guided by Intraoperative In... | NCT06409013

Studies
Evaluation of Tumor Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography in Patients With Sarcoma

NCT06409013

Sponsor

Mayo Clinic

Status

Recruiting

Last Update Posted

Feb 6, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Bone Sarcoma
Soft Tissue Sarcoma

Interventions

Non-Interventional Study

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

ID	Type	Description	Link
NCI-2024-03482	Registry Identifier	CTRP (Clinical Trial Reporting Program)
23-003589	Other Identifier	Mayo Clinic Institutional Review Board

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2024Actual

Primary Completion Date

Mar 30, 2027Estimated

Completion Date

Mar 30, 2027Estimated

First Submitted Date

May 7, 2024

First Submission Date that Met QC Criteria

May 7, 2024

First Posted Date

May 10, 2024Actual

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

Feb 4, 2026

Last Update Posted Date

Feb 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates the effectiveness of intraoperative indocyanine green dye and fluoroscopic technology in confirming negative margins after tumor removal.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the use of indocyanine green (ICG) as an intraoperative guide during bone and soft tissue sarcoma resection.

OUTLINE: This is an observational study.

Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non-interventional study	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of intraoperative ICG fluorescence compared to final pathology results	Intraoperative ICG fluorescence and deduced margins will be analyzed and compared the accuracy to final pathology margins. Negative predictive value will be calculated.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection

Exclusion Criteria:

* Age less than 18
- Chronic kidney disease
- Anaphylaxis to dyes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection recruited through Mayo Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clinical Trials Referral Office	Contact	855-776-0015		mayocliniccancerstudies@mayo.edu
Laura Dohrmann	Contact	507-266-5886		Beinborn.Laura@mayo.edu

Overall Officials

Name	Affiliation	Role
Matthew T. Houdek, M.D.	Mayo Clinic in Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester	Recruiting	Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D001859	Bone Neoplasms
D012509	Sarcoma

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided