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Benign NeoplasmDiagnostics and screeningDrugDevicePhase 2

What this study is

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.

What's being tested

  • Indocyanine green

    Intervention · DRUG

  • SPY-PHI

    Intervention · DEVICE

Both interventions

The 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.

Study details

Official title
Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
Sponsor
Massachusetts General Hospital
Conditions
Benign Neoplasm · Malignant Neoplasm
Enrolling
100 people
Starts
2022-05-25
Est. completion
2030-04-01
Design
Open-label, single group, Phase 2
Record
View on ClinicalTrials.gov ↗