Fluorescence-Guided Optimization of Sarcoma Margins
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biopsy verified intermediate-to-high grade sarcoma of theextremity or trunk wall
Age>18 years old
Tumor operable
Curative intent at time of surgery
Disqualifiers
History of allergic reaction to iodine-containing pharmaceuticals
End-stage renal disease or eGFR <15
Patient decision
Lack of capacity
Trial design
Design model
Single group
Treatments tested in this trial
Fluorescent-guided Surgery
Procedure/SurgerySurgical 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
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Fluorescence-guided surgery cohortExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov