Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Massachusetts General Hospital
No Placebo Group
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This trial uses a special dye called ICG to help surgeons see and remove bone or soft tissue tumors more effectively. The dye lights up the tumor under a special camera, making it easier to ensure all of it is removed. This approach aims to improve surgical outcomes for patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the drug Indocyanine Green (ICG) for cancer surgery?
Research shows that Indocyanine Green (ICG) is effective in helping surgeons see and remove tumors more safely by highlighting important structures and improving surgical outcomes. It is used in various surgeries, including colorectal and breast cancer, to identify lymph nodes and assess blood flow, making surgeries more precise and reducing complications.
12345Is indocyanine green (ICG) dye safe for use in humans?
Indocyanine green (ICG) dye is generally considered safe for use in humans, but rare adverse effects like severe hemodynamic instability (serious blood flow issues) and anaphylactoid reactions (severe allergic reactions) have been reported.
36789How is the drug Indocyanine green (ICG) unique for cancer surgery?
Indocyanine green (ICG) is unique for cancer surgery because it is a dye that helps surgeons see tumors and important structures during surgery using fluorescence (a special light that makes the dye glow). This makes it easier to locate tumors and ensure proper blood flow to tissues, which is different from traditional methods that don't use this glowing effect.
1011121314Eligibility Criteria
This trial is for adults over 18 with benign or malignant bone or soft tissue masses who are undergoing surgery at Massachusetts General Hospital's Orthopaedic Surgery Department. It excludes those in renal failure not cleared for ICG, pregnant or nursing individuals, and patients with known anaphylaxis to IV contrast or iodine.Inclusion Criteria
I am 18 or older with a bone or soft tissue mass and am scheduled for surgery at Massachusetts General Hospital.
Exclusion Criteria
My doctor says I can't have ICG due to kidney failure.
Participant Groups
The study tests the effectiveness of using a dye called indocyanine green (ICG) during surgical removal of tumors to achieve clear margins. The goal is to see if this method reduces local recurrence, delays metastasis, and improves survival rates compared to traditional methods.
1Treatment groups
Experimental Treatment
Group I: ICG Dye and use of SPY-PHI ImagingExperimental Treatment2 Interventions
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
Indocyanine green is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Indocyanine green for:
- Diagnostic imaging of the lymphatic system
- Ophthalmic angiography
- Cardiovascular imaging
🇪🇺 Approved in European Union as Indocyanine green for:
- Diagnostic imaging of the lymphatic system
- Ophthalmic angiography
- Cardiovascular imaging
🇨🇦 Approved in Canada as Indocyanine green for:
- Diagnostic imaging of the lymphatic system
- Ophthalmic angiography
- Cardiovascular imaging
🇯🇵 Approved in Japan as Indocyanine green for:
- Diagnostic imaging of the lymphatic system
- Ophthalmic angiography
- Cardiovascular imaging
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
References
Sentinel node mapping using indocyanine green and near-infrared fluorescence imaging technology for endometrial cancer: A prospective study using a surgical algorithm in Indian patients. [2022]Indocyanine green (ICG) fluorescence with high-definition, three-dimensional imaging systems is emerging as the latest strategy to reduce trauma and improve surgical outcomes during oncosurgery.
Indocyanine Green (ICG) and Colorectal Surgery: A Literature Review on Qualitative and Quantitative Methods of Usage. [2023]Background: Due to its many benefits, indocyanine green (ICG) has gained progressive popularity in operating rooms (ORs) globally. This literature review examines its qualitative and quantitative usage in surgical treatment. Method: Relevant terms were searched in five international databases (1. Pubmed, 2. Sciencedirect, 3. Scopus, 4. Oxfordjournals, 5. Reaxys) for a comprehensive literature review. The main benefits of using ICG in colorectal surgery are: intraoperative fluorescence angiography; fluorescence-guided lymph node involvement detection and the sentinel technique; the fluorescent emphasis of a minute liver tumour, counting just 200 tumour cells; facilitation of fistula diagnosis; and tumour tattooing. This methodology can also be used with quantitative characteristics such as maximum intensity, relative maximum intensity, and in-flow parameters such as time-to-peak, slope, and t1/2max. This article concludes that fluorescence surgery with ICG and near-infrared (NIR) light is a relatively new technology that improves anatomical and functional information, allowing more comprehensive and safer tumour removal and the preservation of important structures.
[Use of indocyanine green angiography in oncological and reconstructive breast surgery]. [2018]The Indocyanine green (ICG) is a soluble dye that is eliminated by the liver and excreted in bile. When illuminated by an near-infrared light, the ICG emits fluorescence in the near-infrared spectrum, which can be captured by a near-infrared camera-handled device. In case of intravenous injection, ICG may be used as a marker of skin perfusion. In case of interstitial injection, it may be useful for lymphatic network mapping. In oncological and reconstructive breast surgery, ICG is used for sentinel lymph node identification, to predict mastectomy skin flap necrosis, to assess the perfusion of free flaps in autologous reconstruction and for diagnosis and treatment of upper limb secondary lymphedema. Intraoperative indocyanine green fluorescence might also be used to guide the excision of nonpalpable breast cancer.
Indocyanine green fluorescence angiography during liver and pancreas transplantation: a tool to integrate perfusion statement's evaluation. [2022]Indocyanine green (ICG) fluorescence imaging is a promising tool for intraoperative decision-making during surgical procedures, in particular to assess organs perfusion.
Indocyanine green (ICG) fluorescence guide for the use and indications in general surgery: recommendations based on the descriptive review of the literature and the analysis of experience. [2022]Indocyanine Green is a fluorescent substance visible in near-infrared light. It is useful for the identification of anatomical structures (biliary tract, ureters, parathyroid, thoracic duct), the tissues vascularization (anastomosis in colorectal, esophageal, gastric, bariatric surgery, for plasties and flaps in abdominal wall surgery, liver resection, in strangulated hernias and in intestinal ischemia), for tumor identification (liver, pancreas, adrenal glands, implants of peritoneal carcinomatosis, retroperitoneal tumors and lymphomas) and sentinel node identification and lymphatic mapping in malignant tumors (stomach, breast, colon, rectum, esophagus and skin cancer). The evidence is very encouraging, although standardization of its use and randomized studies with higher number of patients are required to obtain definitive conclusions on its use in general surgery. The aim of this literature review is to provide a guide for the use of ICG fluorescence in general surgery procedures.
Severe hemodynamic instability after indocyanine green injection during off-pump coronary artery bypass grafting: A case report. [2022]The increasingly intraoperative use of indocyanine green (ICG) means that it is necessary to be aware of both its advantages and potential adverse effects.
Short-term and long-term outcomes of indocyanine green for sentinel lymph node biopsy in early-stage breast cancer. [2022]Indocyanine green (ICG) is becoming a frequently used sentinel lymph node (SLN) tracer of breast cancer in China. However, there is still a lack of data on its safety. We reported the clinical outcome of ICG as a tracer of SLN over a median 67-month follow-up period to evaluate its feasibility in clinically node-negative patients with breast cancer.
Fluorescence Imaging Using Indocyanine Green Dye in the Pediatric Population. [2020]Fluorescence imaging using indocyanine green (ICG) allows for the intraoperative mapping of the vascular supply of various tissue beds. Although generally safe and effective, rare adverse effects have been reported including anaphylactoid reactions. The current study retrospectively reviewed our experience the intraoperative administration of ICG to pediatric patients.
The primary application of indocyanine green fluorescence imaging in surgical oncology. [2023]Indocyanine green (ICG) is a nontoxic, albumin-bound, liver-metabolized fluorescent iodide dye that has been widely utilized in clinical applications since the mid-1950s. However, after the 1970s, in-depth research on the fluorescence properties of ICG greatly expanded its application in the medical field.
Optimal ICG dosage of preoperative colonoscopic tattooing for fluorescence-guided laparoscopic colorectal surgery. [2022]Indocyanine green (ICG) is a multifunctional dye used in tumor localization, tissue perfusion, and lymph node (LN) mapping during fluorescence-guided laparoscopic colorectal surgery.
Indocyanine Green: Historical Context, Current Applications, and Future Considerations. [2022]Indocyanine green (ICG) is a dye used in medicine since the mid-1950s for a variety of applications in in cardiology, ophthalmology, and neurosurgery; however, its fluorescent properties have only recently been used in the intraoperative evaluation of tissue perfusion.
Application of Fluorescent Dyes in Visceral Surgery: State of the Art and Future Perspectives. [2022]Through the improvement and implementation of advanced intraoperative imaging, the indications for intraoperative fluorescence have spread to various fields of visceral surgery. Indocyanine green (ICG)-based fluorescence angiography and the imaging systems using this certain dye are currently the cornerstone of intraoperative, fluorescence-based medical imaging.
Clinical Application of Indocyanine Green Fluorescence Technology in Laparoscopic Radical Gastrectomy. [2022]This study aimed to observe the application and evaluate the feasibility and safety of indocyanine green (ICG) fluorescence technology in laparoscopic radical gastrectomy (LRG).
Multifunctional Indocyanine Green Applications for Fluorescence-Guided Laparoscopic Colorectal Surgery. [2021]Indocyanine green (ICG) could be applied for multiple functions such as fluorescent tumor localization, fluorescence lymph node mapping (FLNM), and intraoperative angiography in colorectal cancer surgery. With the near-infrared (NIR) systems, colonoscopic ICG tattooing can be used to define the early colorectal cancer that cannot be easily distinguished through the serosal surface. The lymphatic pathways can be visualized under the NIR system when ICG is injected through the submucosal or subserosal layer around the tumor. Intraoperative ICG angiography can be applied to find a favorable perfusion segment before the colon transection. Although all fluorescence functions are considered essential steps in image-guided surgery, it is difficult to perform multifunctional ICG applications in a single surgical procedure at once because complex protocols could interfere with each other. Therefore, we review the multifunctional ICG applications for fluorescent tumor localization, FLNM, and ICG angiography. We also discuss the optimal protocol for fluorescence-guided colorectal surgery.