ICG for Cancer
(T-LyM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to identify lymph nodes affected by cancer in children with solid tumors. The technique uses Indocyanine Green (ICG), a special dye, to highlight these nodes during surgery, helping surgeons determine which lymph nodes to remove or sample. It targets children already scheduled for a procedure to check their lymph nodes due to cancer. This trial is ideal for pediatric patients at the University of Rochester Medical Center with solid tumors who require lymph node sampling. As a Phase 2 trial, it measures the effectiveness of this technique in an initial, smaller group of patients, providing an opportunity to contribute to important research.
Do I need to stop my current medications for the trial?
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 prior data suggests that this method is safe for detecting sentinel lymph nodes in pediatric patients?
Previous studies have shown that indocyanine green (ICG) is safe and effective. Research indicates that using ICG during surgeries can help reduce complications. For instance, in surgeries to remove stomach cancer, ICG proved safe and enhanced the visibility of critical areas for doctors.
Another study found that ICG reliably identifies sentinel lymph nodes, the first nodes where cancer might spread. Specifically, ICG successfully identified 94% of these nodes, outperforming other methods.
Overall, ICG is generally well-tolerated, with no serious side effects widely reported. This makes it a promising option for assisting doctors during surgeries.12345Why are researchers excited about this trial?
Indocyanine Green (ICG) is unique because it uses a special dye that can highlight cancerous tissues during surgery. Unlike traditional treatments, which rely heavily on visual inspection and imaging techniques like MRIs or CT scans, ICG allows surgeons to see cancer cells in real-time. This can potentially lead to more precise removal of tumors, reducing the risk of leaving behind cancerous tissues. Researchers are excited because this approach could improve surgical outcomes and minimize the need for additional treatments.
What evidence suggests that ICG-guided intraoperative lymphography is effective for detecting sentinel lymph nodes in pediatric patients with solid tumors?
Research has shown that Indocyanine Green (ICG), which participants in this trial will receive, enhances tumor visibility during surgery, aiding in the precise targeting of cancer cells. Studies have found that ICG imaging can identify tumors very effectively, with many reporting a 100% success rate. Using ICG in surgeries also results in smaller surgical margins, leaving fewer cancer cells behind and reducing the risk of recurrence. Additionally, ICG has improved long-term outcomes for patients undergoing lymph node procedures, such as those with stomach cancer. Overall, ICG is considered a safe and effective tool for enhancing surgical precision and outcomes in cancer treatments.26789
Are You a Good Fit for This Trial?
This trial is for children under 18 with solid tumors who are being treated at the University of Rochester Medical Center and need lymph node sampling as part of their treatment.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Injection of ICG directly into lymphatics draining the primary tumor and intraoperative lymphography for detecting sentinel lymph nodes
Follow-up
Participants are monitored for safety and effectiveness after surgery, with pathology reports finalized within 7 days
What Are the Treatments Tested in This Trial?
Interventions
- ICG (Indocyanine Green)
Trial Overview
The study tests if using a dye called Indocyanine Green (ICG) during surgery can safely help doctors find important lymph nodes in kids with solid tumors. The dye is injected while the child is asleep for surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Rochester
Lead Sponsor
Citations
Efficacy and safety of indocyanine green fluorescence ... - PMC
This comprehensive meta-analysis demonstrates that the use of ICG fluorescence imaging during surgery is associated with a significant reduction ...
Indocyanine green fluorescence imaging-guided versus ...
Our study shows that laparoscopic ICG fluorescence imaging-guided lymphadenectomy can improve the long-term OS and DFS of patients with GC and ...
Comparison of Indocyanine Green with conventional tracers ...
For this study, ICG is considered for the tracing of SLN in the SLNB in breast surgery procedures thanks to its broad applicability, cost- ...
Efficacy of indocyanine green fluorescence for the ... - PMC - NIH
All studies achieved a 100 per cent tumour identification rate with indocyanine green fluorescence, except for one study, with an identification ...
Intraoperative Tumor Margin Identification With ICG Dye ...
Tumor Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography Results in Negative Surgical Margins and Decreased Local Recurrence ...
Safety and efficacy of indocyanine green near-infrared ... - PMC
ICG near-infrared fluorescent imaging-guided lymphadenectomy was considered to be safe and effective in gastrectomy.
Safety and efficacy of indocyanine green fluorescence ...
In total, 33 out of the 40 lesions were identified by ICG-fluorescence imaging technique, with the sensitivity of 82.5%. The sensitivity of ICG-fluorescence ...
Evaluation of indocyanine green (ICG) and handheld ...
This research plans to assess hand-held fluorescence imager using ICG dye for feasibility, ergonomics, accuracy and applicability in all gynecologic cancers.
Implementation of Indocyanine Green to Identify Sentinel ...
The method uses a dye called indocyanine green (ICG) and a special camera to see the lymph node. The sentinel lymph node is the first lymph node that cancer is ...
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