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ICG Dye Imaging for Tumor Margin Identification

This study is investigating if using a special dye called indocyanine green (ICG) with a device called SPY-PHI can help surgeons better identify tumor margins (edges) during surgery for benign (non-cancerous) or malignant (cancerous) bone or soft tissue masses. The goal is to see if this method leads to more complete tumor removal and reduces the chance of the tumor coming back. You might receive ICG as an injection before or during surgery. During surgery, the SPY-PHI device will use the ICG to highlight tumor areas. The study aims to enroll 100 participants who are at least 18 years old and are having surgery for a bone or soft tissue mass at Massachusetts General Hospital. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants receive a specific intervention (ICG dye and SPY-PHI imaging). It plans to enroll 100 participants.
What's involved
You would receive an ICG injection before or during surgery. During surgery, the SPY-PHI device will be used to image the tumor and tumor bed. Tumor samples will be collected and analyzed.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the prediction of local recurrence for up to 2 years after surgery.

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NCT04752137

Intraoperative Tumor Margin Identification With ICG Dye Imaging

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Massachusetts General Hospital
~100 participants
Updated 2026-04-24 on ClinicalTrials.gov
What's tested:Indocyanine greenSPY-PHI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
image-guided prediction of local recurrence
Measured over 2 Years

Conditions

Benign Neoplasm
Malignant Neoplasm

Explore related trials

Benign NeoplasmMalignant Neoplasm

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Santiago A Lozano-Calderon, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Santiago A Lozano-Calderon, MD, PhD
[email protected]
(617) 643-4947
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • image-guided prediction of local recurrence2 Years

    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.