Intraoperative Tumor Margin Identification With ICG Dye Imaging
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
In this research study we want to learn more about the use of indocyanine green (ICG) during bone or soft tissue mass resections. Indocyanine green (ICG) is a type of dye that is used in medical diagnostics. We want to determine if ICG-guided tumor resection is more effective in obtaining negative margins. Lastly, we want to assess traditional oncologic outcomes of local recurrence, time to metastatic disease, and overall and disease specific survival.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients 18 years of age or older who present to Massachusetts General Hospital Department of Orthopaedic Surgery with a benign or malignant bone or soft tissue mass that is consented for surgery during the study period.
Disqualifiers
Pregnant or nursing patients
Patients with previously known anaphylaxis to IV contrast or iodine (other allergies may be considered on a case-by-case basis)
Patients in renal failure who are not cleared for ICG administration by their primary physician or oncologist
Trial design
Design model
Single group
Treatments tested in this trial
Indocyanine green
DrugThe SPY PHI and its dye Indocyanine Green dye (ICG) is a non-invasive device that is connected to a light source tower that is already available in the hospital in the operating room under Gynecology and Obstetrics Equipment. This is a special light source lamp that allows to test for vascularity in the soft tissues intraoperatively. Previous research in animal models proved the concept that the increased vascularity in tumors can be used to use this device to improve intraoperative assessment of tumor margins during resection. Our study will help to establish a correlation between activity with the dye and histological findings. This information has the potential to help sarcoma patients by avoiding staged surgeries, decreasing hospitalization times, and decreasing the likelihood of local recurrence by improving margin quality.
SPY-PHI
DeviceThe SPY PHI and its dye Indocyanine Green dye (ICG) is a non-invasive device that is connected to a light source tower that is already available in the hospital in the operating room under Gynecology and Obstetrics Equipment. This is a special light source lamp that allows to test for vascularity in the soft tissues intraoperatively. Previous research in animal models proved the concept that the increased vascularity in tumors can be used to use this device to improve intraoperative assessment of tumor margins during resection. Our study will help to establish a correlation between activity with the dye and histological findings. This information has the potential to help sarcoma patients by avoiding staged surgeries, decreasing hospitalization times, and decreasing the likelihood of local recurrence by improving margin quality.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: ICG Dye and use of SPY-PHI ImagingOther 2 interventions
Trial outcomes
Primary outcomes
1
image-guided prediction of local recurrence
The primary outcome of this work is image-guided prediction of local recurrence, defined as pathologically confirmed return of the resected tumor local to the prior excision bed within 2 years of the primary surgery.
Time frame
2 YearsSecondary outcomes
1
Distant recurrence (metastatic disease)
If a participant develops metastatic disease after surgery with ICG and SPY-PHI.
Time frame
2 Years2
physician-perceived vs. device measured negative margins
physician-perceived vs. device measured negative margins (compared using pathologic specimens), which will be measured against formal margin analysis performed by a pathologist during the routine standard of care.
Time frame
14 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov