Fluorescence-Guided Optimization of Sarcoma Margins

NCT07134192 | Recruiting

• 2 other identifiers: 1139421-10-72-34-25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sarcoma; Soft Tissue Sarcoma of the Trunk and Extremities

Keywords

Sarcoma; ICG; Indocyanine green; Fluorescence Guided Surgery; FGS; STS; Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Reresection

  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

Study Arms (1)

Fluorescence-guided surgery cohort

EXPERIMENTAL

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 the day prior to surgery.

Procedure: Fluorescent-guided Surgery

Interventions

Fluorescent-guided Surgery PROCEDURE

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

Fluorescence-guided surgery cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (2)

Aarhus University Hospital

Aarhus N, 8200, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Thomas Baad-Hansen, MD, PhD

  Orthopedic Surgical Department, Aarhus University Hospital

  STUDY DIRECTOR

• Christian Kveller, MD

  Orthopedic Surgical Department, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Kveller, MD

CONTACT

+45 51 48 13 19; chrkve@rm.dk

Thomas Baad-Hansen, MD, PhD

CONTACT

+45 28603490; thombaad@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: National multicenter interventional cohort study

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)