Fluorescence-Guided Optimization of Sarcoma Margins

NCT ID: NCT07134192

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-03-01

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.

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 16-24 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.

Conditions

Soft Tissue Sarcoma of the Trunk and Extremities; Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 the day prior to surgery.

Group Type: EXPERIMENTAL

Fluorescent-guided Surgery

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Baad-Hansen, MD, PhD

Role: STUDY_DIRECTOR

Orthopedic Surgical Department, Aarhus University Hospital

Christian Kveller, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Surgical Department, Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus N, , Denmark

Site Status: RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status: NOT_YET_RECRUITING

Countries

Denmark

Central Contacts

Christian Kveller, MD

Role: CONTACT

chrkve@rm.dk

+45 51 48 13 19

Thomas Baad-Hansen, MD, PhD

Role: CONTACT

thombaad@rm.dk

+45 28603490

Facility Contacts

Christian Kveller, MD

Role: primary

chrkve@rm.dk

+45 51 48 13 19

Thomas Baad-Hansen, MD, PhD

Role: backup

thombaad@rm.dk

+45 28603490

Michael M Petersen, MD, PhD

Role: primary

Michael.Moerk.Petersen@regionh.dk

+45 3545 8900

Other Identifiers

1-10-72-34-25

Identifier Type: OTHER

Identifier Source: secondary_id

113942

Identifier Type: -

Identifier Source: org_study_id