Intraoperative Tumor Margin Identification With ICG Dye Imaging

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04752137
Phase
PHASE2
Status
Recruiting
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Conditions

  • Benign Neoplasm
  • Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Indocyanine green — DRUG
    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.
  • SPY-PHI — DEVICE
    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

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.

Key Dates

Start date
May 25, 2022
Status verified
Apr 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: ICG Dye and use of SPY-PHI Imaging
    ICG will be administered in the pre-operative unit via IV injection at the time that they present to the pre-operative unit, which is approximately 4 hours before surgery. ICG Angiography (SPY PHI) will be performed to detect any residual signal

Primary Outcome Measure

image-guided prediction of local recurrence [ Time Frame: 2 Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Santiago A Lozano-Calderon, MD, PhD
[email protected]
617-643-4947
Shreya Halur, BS
[email protected]
617-726-4932

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By research site
Massachusetts General Hospital· Boston, MA

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