Fluorescence-Guided Optimization of Sarcoma Margins (FOCUS)

June 29, 2026 updated by: University of Aarhus
This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.

Biopsy verified intermediate-to-high grade sarcoma of the extremity or trunk wall are eligible for inclusion. To be included there must be curative intent at time of surgery.

The primary endpoint will be re-resection within 30 days due to positive margins on the initial resection. Tumor characteristics and margin status from pathology reports will be recorded. Data on reoperations due to other factors, positive margins without planned reoperation, or death will also be collected. Participants will undergo surgery with ICG administered and guided using the SPY-PHI.

The prospective cohort will be compared to a historic cohort having received standard of care treatment. The historic cohort is included to act as a control group to compare with the new procedure. The data is derived from the Danish Sarcoma Database and permissions for this is in process. This data does not involve access to patient EMRs.

Patients will receive an intravenous bolus of 1 mg/kg fluorescent ICG dye 2-24 hours before surgery. During surgery, consecutive measurements will be recorded using the SPY-PHI. Surgical resection will be guided by the fluorescent signal. The wound bed will be inspected, areas with fluorescent signal will be excised and obtained separately for histopathology. Patients will receive the current post-operative standard of care for sarcoma patients.

Approximately 20 minutes of additional surgical time is expected.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

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

  • Name: Christian Kveller, MD
  • Phone Number: +45 51 48 13 19
  • Email: chrkve@rm.dk

Study Contact Backup

  • Name: Thomas Baad-Hansen, MD, PhD
  • Phone Number: +45 28603490
  • Email: thombaad@rm.dk

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Christian Kveller, MD
          • Phone Number: +45 51 48 13 19
          • Email: chrkve@rm.dk
        • Contact:
          • Thomas Baad-Hansen, MD, PhD
          • Phone Number: +45 28603490
          • Email: thombaad@rm.dk
        • Sub-Investigator:
          • Christian Kveller, MD
        • Principal Investigator:
          • Thomas Baad-Hansen, MD, PhD
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Michael M Petersen, MD, PhD
        • Sub-Investigator:
          • Christina E Holm, MD, PhD

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

Description

Inclusion Criteria:

  • Biopsy verified intermediate-to-high grade sarcoma of theextremity or trunk wall
  • Age>18 years old
  • Tumor operable
  • Curative intent at time of surgery
  • Consent of patient

Exclusion Criteria:

  • History of allergic reaction to iodine-containing pharmaceuticals
  • End-stage renal disease or eGFR <15
  • Patient decision
  • Lack of capacity
  • Inoperability

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluorescence-guided surgery cohort
Patients with intermediate-to-high grade sarcomas eligible for curative surgical treatment at time of surgery. Surgery will be augmented by guidance through the use of a near-infrared camera and fluorescent dye administered hours prior to surgery.
Procedure: Fluorescent-guided Surgery
Surgical treatment of the patient group will include the administration of a fluorescent dye and intraoperatively the resection will be aided and guided by the fluorescent signal. The wound bed will be inspected, areas with fluorescent signal will be excised and obtained separately for histopathology. Patients will receive the current post-operative standard of care for sarcoma patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reresection
Time Frame: 30 days
Reresection within 30 days will be used as primary endpoint as a proxy for histopathologically positive margin status following surgery which would require reoperation.
30 days

Collaborators and Investigators

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

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Thomas Baad-Hansen, MD, PhD, Orthopedic Surgical Department, Aarhus University Hospital
  • Study Director: Christian Kveller, MD, Orthopedic Surgical Department, Aarhus University Hospital

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)

September 1, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

August 13, 2025

First Submitted That Met QC Criteria

August 20, 2025

First Posted (Actual)

August 21, 2025

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 29, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113942
  • 1-10-72-34-25 (Other Identifier: Scientific Ethics Committees for the Central Denmark Region)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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