Fluorescence-Guided Optimization of Sarcoma Margins (FOCUS)

University of Aarhus

Status: Enrolling

Conditions: Soft Tissue Sarcoma of the Trunk and Extremities; Sarcoma

Treatments: Procedure: Fluorescent-guided Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07134192

113942

1-10-72-34-25 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Fluorescence-guided surgery cohort

Experimental group

Description:

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.

Treatment:

Procedure: Fluorescent-guided Surgery