Recruiting
Phase 2

ICG Dye Imaging

Sponsor:

Massachusetts General Hospital

Code:

NCT04752137

Conditions

Benign Neoplasm

Malignant Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Indocyanine green

SPY-PHI

Study Details

Brief summary:

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.

Conditions

Benign Neoplasm

Malignant Neoplasm

Study ID

NCT04752137

Start date

May 25, 2022

Status verified date

Apr, 2026

Completion date

Apr 1, 2030

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

Indocyanine green

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Santiago A Lozano-Calderon, MD, PhD

(617) 643-4947SLOZANOCALDERON@mgh.harvard.edu

Shreya Halur, BS

(617) 726-4932shalur@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Santiago A Lozano-Calderon, MD, PhD

617-643-4947slozanocalderon@mgh.harvard.edu

Shreya Halur, BS

617-726-4932shalur@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-24.