Clinical trial · Interventional
Intraoperative Tumor Margin Identification With ICG Dye Imaging
Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
NCT04752137CI-TRIAL-00109374recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Neoplasm | Benign Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
| SPY-PHI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ICG Dye and use of SPY-PHI Imaging
- description
- 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
- interventionNames
- Drug: Indocyanine green
- Device: SPY-PHI
Primary outcomes (1)
- measure
- image-guided prediction of local recurrence
- timeFrame
- 2 Years
- description
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDWasif N. Comparative effectiveness research for sarcoma. Cancer Treat Res. 2015;164:51-65. doi: 10.1007/978-3-319-12553-4_4. PMID 25677018
- BACKGROUNDFourman 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
- BACKGROUNDHarati 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
- BACKGROUNDRath 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
- BACKGROUNDGoertz 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
- BACKGROUNDHarati 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
- BACKGROUNDFourman 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.