Sarcoma, Soft Tissue Sarcoma of the Trunk and Extremities
Conditions
Keywords
Sarcoma, ICG, Indocyanine green, Fluorescence Guided Surgery, FGS, STS, Soft Tissue Sarcoma
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 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.
Interventions
PROCEDUREFluorescent-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
Sponsors
University of Aarhus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
National multicenter interventional cohort study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reresection | 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. |
Countries
Denmark
Contacts
CONTACTChristian Kveller, MD
CONTACTThomas Baad-Hansen, MD, PhD
PRINCIPAL_INVESTIGATORThomas Baad-Hansen, MD, PhD
Orthopedic Surgical Department, Aarhus University Hospital
STUDY_DIRECTORChristian Kveller, MD
Orthopedic Surgical Department, Aarhus University Hospital
Outcome results
None listed