Indocyanine Green for Vulvar Cancer
(IGNITE-V Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether a special dye, indocyanine green (ICG), can help doctors identify important lymph nodes in women with early-stage vulvar cancer. Typically, doctors use a combination of techniques to locate these nodes, but the study aims to determine if ICG alone can perform this task effectively. Women with a specific type of vulvar cancer, featuring a tumor smaller than 4 cm and no signs of cancer spread in nearby areas, may qualify for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants, offering them a chance to contribute to significant advancements in cancer care.
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.
What prior data suggests that this method is safe for sentinel lymph node detection in early stage vulvar cancer?
Research has shown that indocyanine green (ICG) is safe for identifying sentinel lymph nodes in early-stage vulvar cancer. One study found that injecting ICG around the tumor to map lymph nodes did not cause major safety issues, suggesting that patients generally tolerate the treatment well. Another study confirmed that using only ICG is both safe and practical for detecting lymph nodes in vulvar cancer patients. In both studies, no major side effects were reported, indicating that the treatment is safe based on current evidence.12345
Why are researchers excited about this trial?
Indocyanine Green (ICG) is unique because it uses a fluorescence imaging technique to detect sentinel lymph nodes (SLN) in early vulvar cancer. Unlike current standard treatments, which often rely on blue dye and radioactive tracers, ICG provides real-time visualization, potentially improving accuracy and reducing invasiveness. Researchers are excited about this method because it could lead to more precise surgeries with fewer side effects, offering a significant advancement in the management of vulvar cancer.
What evidence suggests that Indocyanine Green might be an effective treatment for vulvar cancer?
Studies have shown that indocyanine green (ICG) effectively identifies sentinel lymph nodes in vulvar cancer. Research indicates that ICG achieves an 86% success rate when used alone, nearly matching current standard methods. In many cases, ICG proves just as accurate as traditional dual techniques. It is safe and offers a detection rate comparable to other methods. This trial will evaluate ICG alone for detecting sentinel lymph nodes in early vulvar cancer, suggesting that ICG might reliably identify lymph nodes in patients with early-stage vulvar cancer.34567
Are You a Good Fit for This Trial?
This trial is for people with early-stage vulvar cancer who are candidates for sentinel lymph node detection. Participants should not have conditions that would prevent them from safely undergoing the procedure.Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo sentinel lymph node detection using ICG alone or ICG plus Technetium
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Indocyanine Green
Trial Overview
The study compares using indocyanine green (ICG) dye alone versus the standard method of ICG plus technetium to find sentinel lymph nodes during surgery for vulvar cancer.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
ICG alone for the detection of SLN in early vulvar cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hamilton Health Sciences Corporation
Lead Sponsor
Juravinski Cancer Centre Foundation
Collaborator
Citations
The use of indocyanine green (ICG) for sentinel lymph ...
The aim of this study is to evaluate the use of indocyanine green (ICG) as a detection modality in sentinel lymph node (SLN) procedures for vulvar cancer.
Indocyanine green fluorescent image-guided inguinal sentinel ...
This video demonstrates a successful ICG fluorescence image-guided left inguinal SLN biopsy in a vulvar cancer patient using a laparoscopic camera.
3.
contemporaryobgyn.net
contemporaryobgyn.net/view/indocyanine-green-shows-accuracy-for-detecting-vulvar-cancerIndocyanine green shows accuracy for detecting vulvar ...
The combined per-patient detection rate across all methods was 92%, with ICG demonstrating 86% efficacy as a standalone tracer. SPIO achieved a ...
Diagnostic value of indocyanine green fluorescence ...
ICG for SLN mapping appears to be safe in women with vulvar cancer with a detection rate similar to the current techniques.
5.
researchgate.net
researchgate.net/publication/377142969_Accuracy_of_ICG_compared_with_technetium-99m_for_sentinel_lymph_node_biopsy_in_vulvar_cancerAccuracy of ICG compared with technetium-99m for ...
The main objective of this study is to evaluate the rate and severity of allergic events in all patients with vulvar cancer undergoing surgical ...
Safety of indocyanine green for lymph node mapping in early ...
This study demonstrates that peritumoral injection of indocyanine green for sentinel lymph node mapping in early-stage vulvar cancer is safe, ...
Effectiveness and safety of Indocyanine green (ICG) for ...
Conclusion: Sentinel lymph node biopsy for vulvar cancer with Tc-99 and. ICG appears safe and feasible. ICG may increase the detection rate of micro metastasis.
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