Intraoperative Tumor Margin Identification With ICG Dye Imaging

NCT04752137 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: 2020P003481
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  2 Years

Secondary Outcomes (2)

• Distant recurrence (metastatic disease)

  2 Years

• physician-perceived vs. device measured negative margins

  14 days

Study Arms (1)

ICG Dye and use of SPY-PHI Imaging

OTHER

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

Drug: Indocyanine green; Device: SPY-PHI

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.

ICG Dye and use of SPY-PHI Imaging

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.

ICG Dye and use of SPY-PHI Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (13)

• Wasif N. Comparative effectiveness research for sarcoma. Cancer Treat Res. 2015;164:51-65. doi: 10.1007/978-3-319-12553-4_4.

  PMID: 25677018 BACKGROUND

• Fourman MS, Mahjoub A, Mandell JB, Yu S, Tebbets JC, Crasto JA, Alexander PE, Weiss KR. Quantitative Primary Tumor Indocyanine Green Measurements Predict Osteosarcoma Metastatic Lung Burden in a Mouse Model. Clin Orthop Relat Res. 2018 Mar;476(3):479-487. doi: 10.1007/s11999.0000000000000003.

  PMID: 29408832 BACKGROUND

• Harati K, Lehnhardt M. The changing paradigm of resection margins in sarcoma resection. Innov Surg Sci. 2017 Dec 6;2(4):165-170. doi: 10.1515/iss-2017-0043. eCollection 2017 Dec.

  PMID: 31579750 BACKGROUND

• Rath B, Hardes J, Tingart M, Braunschweig T, Eschweiler J, Migliorini F. [Resection margins in soft tissue sarcomas]. Orthopade. 2019 Sep;48(9):768-775. doi: 10.1007/s00132-019-03795-6. German.

  PMID: 31463543 BACKGROUND

• Goertz O, Pieper A, Lohe LV, Stricker I, Dadras M, Behr B, Lehnhardt M, Harati K. The Impact of Surgical Margins and Adjuvant Radiotherapy in Patients with Undifferentiated Pleomorphic Sarcomas of the Extremities: A Single-Institutional Analysis of 192 Patients. Cancers (Basel). 2020 Feb 5;12(2):362. doi: 10.3390/cancers12020362.

  PMID: 32033261 BACKGROUND

• Harati K, Goertz O, Pieper A, Daigeler A, Joneidi-Jafari H, Niggemann H, Stricker I, Lehnhardt M. Soft Tissue Sarcomas of the Extremities: Surgical Margins Can Be Close as Long as the Resected Tumor Has No Ink on It. Oncologist. 2017 Nov;22(11):1400-1410. doi: 10.1634/theoncologist.2016-0498. Epub 2017 Jul 24.

  PMID: 28739867 BACKGROUND

• Fourman MS, Gersch RP, Levites HA, Phillips BT, Bui DT. Is There a Right Way to Interpret SPY? Normalization of Indocyanine Green Angiography Readings in a Burn Model. Plast Reconstr Surg. 2015 Jul;136(1):128e-130e. doi: 10.1097/PRS.0000000000001380. No abstract available.

  PMID: 25803152 BACKGROUND

• Crasto JA, Fourman MS, Morales-Restrepo A, Mahjoub A, Mandell JB, Ramnath K, Tebbets JC, Watters RJ, Weiss KR. Disulfiram reduces metastatic osteosarcoma tumor burden in an immunocompetent Balb/c or-thotopic mouse model. Oncotarget. 2018 Jul 10;9(53):30163-30172. doi: 10.18632/oncotarget.25733. eCollection 2018 Jul 10.

  PMID: 30046395 BACKGROUND

• Mahjoub A, Morales-Restrepo A, Fourman MS, Mandell JB, Feiqi L, Hankins ML, Watters RJ, Weiss KR. Tumor Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography Results in Negative Surgical Margins and Decreased Local Recurrence in an Orthotopic Mouse Model of Osteosarcoma. Ann Surg Oncol. 2019 Mar;26(3):894-898. doi: 10.1245/s10434-018-07114-9. Epub 2018 Dec 27.

  PMID: 30588559 BACKGROUND

• Gilg MM, Sunitsch S, Leitner L, Bergovec M, Szkandera J, Leithner A, Liegl-Atzwanger B. Tumor-associated mortality and prognostic factors in myxofibrosarcoma - A retrospective review of 109 patients. Orthop Traumatol Surg Res. 2020 Oct;106(6):1059-1065. doi: 10.1016/j.otsr.2020.04.017. Epub 2020 Aug 7.

  PMID: 32778437 BACKGROUND

• Newton AD, Predina JD, Corbett CJ, Frenzel-Sulyok LG, Xia L, Petersson EJ, Tsourkas A, Nie S, Delikatny EJ, Singhal S. Optimization of Second Window Indocyanine Green for Intraoperative Near-Infrared Imaging of Thoracic Malignancy. J Am Coll Surg. 2019 Feb;228(2):188-197. doi: 10.1016/j.jamcollsurg.2018.11.003. Epub 2018 Nov 22.

  PMID: 30471345 BACKGROUND

• Madajewski B, Judy BF, Mouchli A, Kapoor V, Holt D, Wang MD, Nie S, Singhal S. Intraoperative near-infrared imaging of surgical wounds after tumor resections can detect residual disease. Clin Cancer Res. 2012 Oct 15;18(20):5741-51. doi: 10.1158/1078-0432.CCR-12-1188. Epub 2012 Aug 29.

  PMID: 22932668 BACKGROUND

• Holt D, Parthasarathy AB, Okusanya O, Keating J, Venegas O, Deshpande C, Karakousis G, Madajewski B, Durham A, Nie S, Yodh AG, Singhal S. Intraoperative near-infrared fluorescence imaging and spectroscopy identifies residual tumor cells in wounds. J Biomed Opt. 2015 Jul;20(7):76002. doi: 10.1117/1.JBO.20.7.076002.

  PMID: 26160347 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Santiago A Lozano-Calderon, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santiago A Lozano-Calderon, MD, PhD

CONTACT

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

Shreya Halur, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 12, 2021
• Study Start: May 25, 2022
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)