Fluorescent Tumor Margin Examination for Sarcoma
(ICGTM Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byKurt E Weiss
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Kurt Weiss
Disqualifiers: Pregnancy, Renal failure, Fluorescein allergy, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Tumor margin confirmation is important to confirming appropriate disease excision. Current standard of care is to take select margin samples to pathology for intra-operative readings. However, this is expensive, time consuming, and only assesses the margin contained within the specific sample. In prior work the investigators have determined that indocyanine green (ICG) is highly specific to the tumor bed when injected shortly before surgery. The investigators hypothesize that ICG will be able to accurately identify residual positive tumor margins during sarcoma excision procedures.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Indocyanine Green (ICG) Fluorescence Imaging for tumor margin examination in sarcoma?
Research shows that Indocyanine Green (ICG) is effective in identifying sentinel lymph nodes in breast cancer and has been used in photodynamic therapy to inhibit cancer growth, suggesting its potential usefulness in tumor margin examination for sarcoma.
12345Is Indocyanine Green (ICG) safe for use in humans?
Indocyanine Green (ICG) has been used safely in various medical procedures, such as sentinel lymph node mapping in breast and endometrial cancer, with no significant adverse reactions reported. Studies suggest it is generally safe for human use.
25678How does the treatment using fluorescent tumor margin examination for sarcoma differ from other treatments?
This treatment uses indocyanine green (ICG), a fluorescent dye, to help surgeons see the edges of a tumor during surgery, which can improve the chances of removing the entire tumor and reduce the risk of it coming back. This approach is unique because it provides real-time visual guidance during surgery, unlike traditional methods that rely on post-surgery pathology results.
2591011Eligibility Criteria
This trial is for adults over 18 with primary musculoskeletal tumors scheduled for surgery. Candidates must have a tumor that hasn't been removed before and has a risk of coming back. It's not for those under 18, pregnant or breastfeeding women, people who've had previous surgery near the tumor, kidney failure patients, or anyone allergic to contrast media.Inclusion Criteria
I gave my permission for surgery before agreeing to join the study.
I am over 18 and need surgery for a bone or muscle tumor.
My biopsy shows I have a primary soft tissue or bone tumor that hasn't been removed and could recur.
Exclusion Criteria
I have had surgery before on the area where my tumor is located.
You have had a severe allergic reaction to contrast media or fluorescein in the past.
My tumor has not or barely come back after treatment.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Pre-operative
Participants receive ICG injection 2 hours prior to surgery
2 hours
1 visit (in-person)
Surgery
Tumor removal surgery with ICG angiography to detect residual tumor margins
1 day
1 visit (in-person)
Follow-up
Participants are monitored for tumor recurrence and compared with ICG angiography findings
2 years
Participant Groups
The study tests if injecting indocyanine green (ICG) can help surgeons see cancerous tissue edges during sarcoma removal surgeries better than current methods. The Stryker SPY-PHI Imaging Device will be used to visualize the ICG-stained tissues in real-time.
1Treatment groups
Experimental Treatment
Group I: ICG use followed by SPY-PHI imaging.Experimental Treatment2 Interventions
Participants will be injected with 2.0mg/kg of ICG dye to access tumor margin using Stryker SPY imaging technology.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UPMC-Shadyside HospitalPittsburgh, PA
Alma E HeylPittsburgh, PA
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Who Is Running the Clinical Trial?
Kurt WeissLead Sponsor
Stryker NordicIndustry Sponsor
References
Infrared laser activation of indocyanine green inhibits growth in human pancreatic cancer. [2019]Indocyanine green (ICG) is a clinically-approved, water-soluble dye that generates reactive singlet oxygen when activated by infrared light. Infrared light offers the advantage of deeper tissue penetration making ICG photodynamic therapy (PDT) ideal for treatment of intra-abdominal cancers such as pancreatic adenocarcinoma.
Evaluation of learning curve with Indocyanine Green (IcG) versus blue dye for sentinel lymph node biopsy in breast cancer. [2023]Indocyanine green (IcG) is an alternative to isosulfan blue (IB) for sentinel lymph node (SLN) mapping in breast cancer (BC). IcG carries improved cost and safety, but oncologic data upon implementation in practice is limited. We evaluated the learning curve defined as oncologic yield and operative (OR) time for IcG in SLN mapping in BC.
[Photochemotherapy of cutaneous AIDS-associated Kaposi sarcoma with indocyanine green and laser light]. [2019]Indocyanine green (ICG) is a clinically approved dye for diagnostic purposes, which has an absorption peak in the near infrared and remains intravascular due to a high plasma protein binding. Its therapeutic potential in combination with a diode laser was studied for well vascularized cutaneous tumors.
Intravenous and indocyanine green angiography. [2022]Indocyanine green angiography (ICGA) is an adjunct procedure to intravenous sodium fluorescein angiography (IVFA) for evaluation of disorders of the retina. It has particular application when choroidal pathology is implicated or suspected. Indocyanine green (ICG) dye has been used in the medical field since 1956, when it was approved by the Federal Drug Administration for imaging cardiac and hepatic circulations. Indocyanine green is a well-tolerated, tricarbocyanine dye with a molecular weight of 775 daltons that absorbs light at 790 to 805 nm and has a peak emission at 835 nm. While the substance gives off 4% the fluorescence of sodium fluorescein, its spectral properties allow it to be visualized through ocular pigments, blood, and serous fluids.
A feasibility study (ICG-10) of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer. [2022]There is now increasing evidence to support the use of indocyanine green (ICG) for sentinel lymph node (SLN) detection in early breast cancer. The primary objective of this feasibility study (ICG-10) was to determine the sensitivity and safety of ICG fluorescence imaging in sentinel lymph node identification when combined with blue dye and radiocolloid.
Clinical applications of ICG Finger Monitor in patients with liver disease. [2019]The indocyanine green (ICG) Finger Monitor system is a non-invasive indication of ICG concentrations in the blood. In this study, significant correlation was found between the sensor signal voltage and plasma ICG concentrations ranging from 0.04 mg/dl to 1.0 mg/dl (r = 0.998, P
Sentinel lymph node biopsy in patients with endometrial cancer and an indocyanine green or iodinated contrast reaction - A proposed management algorithm. [2022]To describe the incidence of adverse reactions to indocyanine green (ICG) administered during sentinel lymph node (SLN) biopsy for endometrial cancer, and to propose an ICG management algorithm for these patients.
An isotonic preparation of 1 mg/ml indocyanine green is not toxic to hyperconfluent ARPE19 cells, even after prolonged exposure. [2016]To investigate the in vitro toxicity of indocyanine green and infracyanine green (ICG) to cultured ARPE19 cells, in particular with respect to the concentration and time dependence of this toxicity.
Intraoperative Evaluation of Soft Tissue Sarcoma Surgical Margins with Indocyanine Green Fluorescence Imaging. [2023]Soft tissue sarcomas (STS) are rare malignant tumors often associated with poor outcomes and high local recurrence rates. Current tools for intraoperative and definitive margin assessment include intraoperative frozen section and permanent pathology, respectively. Indocyanine green dye (ICG) is a historically safe fluorophore dye that has demonstrated efficacy for intraoperative margin assessment in the surgical management of both breast and gastrointestinal cancers. The utility of ICG in the surgical management of sarcoma surgery has primarily been studied in pre-clinical mouse models and warrants further investigation as a potential adjunct to achieving negative margins. This study is a prospective, non-randomized clinical study conducted on patients with confirmed or suspected STS. Patients younger than 18 years, with a prior adverse reaction to iodine or fluorescein, or with renal disease were excluded from the study. Intravenous ICG was infused approximately three hours prior to surgery at a dosage of 2.0-2.5 mg/kg, and following tumor resection, the excised tumor and tumor bed were imaged for fluorescence intensity. When scanning the tumor bed, a threshold of 77% calibrated to the region of maximum intensity in the resected tumor was defined as a positive ICG margin, according to published protocols from the breast cancer literature. ICG results were then compared with the surgeon's clinical impression of margin status and permanent pathology results. Out of 26 subjects recruited for the original study, 18 soft tissue sarcomas (STS) were included for analysis. Three subjects were excluded for having bone sarcomas, and five subjects were excluded due to final pathology, which was ultimately inconsistent with sarcoma. The average age of patients was 64.1 years old (range: 28-83), with an average ICG dose of 201.8 mg. In 56% (10/18) of patients, ICG margins were consistent with the permanent pathology margins, with 89% specificity. The use of ICG as an intraoperative adjunct to obtaining negative margins in soft tissue sarcoma surgery is promising. However, studies with larger sample sizes are warranted to further delineate the accuracy, optimal dosage, timing, and types of sarcoma in which this diagnostic tool may be most useful.
Intraoperative Near-Infrared Fluorescence Guided Surgery Using Indocyanine Green (ICG) for the Resection of Sarcomas May Reduce the Positive Margin Rate: An Extended Case Series. [2021]Sarcomas are rare, aggressive cancers which can occur in any region of the body. Surgery is usually the cornerstone of curative treatment, with negative surgical margins associated with decreased local recurrence and improved overall survival. Indocyanine green (ICG) is a fluorescent dye which accumulates in sarcoma tissue and can be imaged intraoperatively using handheld near-infrared (NIR) cameras, theoretically helping guide the surgeon's resection margins.
Axillary lymph node recurrence after sentinel lymph node biopsy performed using a combination of indocyanine green fluorescence and the blue dye method in early breast cancer. [2022]There is limited information on indocyanine green (ICG) fluorescence and blue dye for detecting sentinel lymph node (SLN) in early breast cancer. A retrospective study was conducted to assess the feasibility of an SLN biopsy using the combination of ICG fluorescence and the blue dye method.