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

July 31, 2026 updated by: Mayo Clinic

Sarcoma Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthew T. Houdek, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Chronic kidney disease
  • Anaphylaxis to dyes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Matthew T. Houdek, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

August 4, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-003589 (Mayo Clinic Institutional Review Board)
  • NCI-2024-03482 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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