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SLN Mapping and ICG Dye for Vulvar Cancer

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ClinicalTrials.gov Identifier: NCT06035068
Recruitment Status : Not yet recruiting
First Posted : September 13, 2023
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Study Description
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Brief Summary:
Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked about using a different method to find these lymph nodes using a special dye called Indocyanine Green (ICG). This method involves shining a special camera on the skin. So far, no studies have directly compared the ICG method to the standard blue dye. The ICG camera could make things easier for patients and doctors, and more patients might choose to have their lymph nodes checked with this new method. The goal of our study is to see if using the ICG dye is just as good as the standard method of blue dye.

Condition or disease Intervention/treatment
Vulva Cancer Drug: Indocyanine green

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sentinel Lymph Node Mapping and Detection With Indocyanine Green and Spy-Phi Handheld Camera Technology in Early-Stage Vulvar Cancer (PILOT)
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vulvar Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Combined ICG dye and blue tracer dye
This study is being done to see if a different way of finding and removing lymph nodes during surgery, using a special camera and a dye called Indocyanine Green (ICG), works as well as the usual method with blue dye plus a radioactive tracer called radiocolloid. By comparing the two ways directly, we hope to make it simpler for people with vulvar cancer to get their lymph nodes checked during surgery.
 Drug: Indocyanine green
Indocyanine green (ICG) is a fluorescent dye that has been used for the imaging of cancers in the body for more than 30 years.
Other Name: ICG dye


Outcome Measures
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Primary Outcome Measures :
  1. Detection Rate of SLNs using ICG Dye vs Blue Dye at Patient Level [ Time Frame: Data collection at time of surgery ]
    • Report the detection rate of SLNs using ICG dye for sentinel lymph node mapping.
    • Report the detection rate of SLNs using blue dye for sentinel lymph node mapping.
    • Compare the two detection rates using a chi-squared test or Fisher's exact test, depending on the sample size.

  2. Clustered Analysis at the Hemi-Pelvis Level [ Time Frame: Data collection at time of surgery ]
    • Use generalized estimating equations (GEE) or mixed-effects logistic regression models to account for the clustering effect.
    • Include a random effect for each patient to address the correlation between SLNs within the same patient's hemi-pelvis.
    • Assess the significance of dye type using the Wald test or likelihood ratio test.
    • Report odds ratios, confidence intervals, and p-values for the effect of dye type on SLN detection.

  3. 3. Difference in SLNs Detected in Blue vs Green Dye when Data is Clustered at Hemi-Pelvis Level [ Time Frame: Data collection at time of surgery ]
    • Report the proportion of SLNs detected using blue dye in each hemi-pelvis.
    • Report the proportion of SLNs detected using ICG dye in each hemi-pelvis.
    • Use a paired t-test or Mcnemar's test to compare the proportions within each hemi-pelvis.
    • Account for the clustering effect by using mixed-effects models


Secondary Outcome Measures :
  1. Sensitivity, Specificity, and Negative Predictive Value of ICG Dye vs Standard Blue Dye [ Time Frame: Data collection at time of surgery ]
    • Create a 2x2 contingency table for sensitivity, specificity, and negative predictive value.
    • Sensitivity = (True Positives) / (True Positives + False Negatives).
    • Specificity = (True Negatives) / (True Negatives + False Positives).
    • Negative Predictive Value = (True Negatives) / (True Negatives + False Negatives).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
10 participants fitting the above criteria at Tufts Medical Center
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Patients with early-stage SCC (diameter <4 cm) of the vulva without suspicious lymph nodes at palpation or imaging who are planned for surgery at Tufts Medical Center.
  • Patients with squamous cell carcinoma, depth of invasion > 1mm
  • Patients with T1 or T2 tumors (FIGO staging) < 4 cm, not encroaching in urethra or anus with clinically negative inguinofemoral lymph nodes
  • Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible
  • Preoperative imaging do not show enlarged (<1.5 cm)/ suspicious nodes
  • Willing and able to give informed consent

Exclusion Criteria:

  • Inoperable tumors and tumors with diameter > 4 cm
  • Patients with inguinofemoral lymph nodes that are palpable on clinical exam suspicious for metastases or with cytologically proven inguinofemoral lymph node metastases
  • Radiologically enlarged (>1.5 cm) inguinofemoral lymph nodes
  • Patients with multifocal tumors
  • Pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035068


Contacts
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Contact: Rafael Gonzalez, MD 617-636-6058 rafael.gonzalez@tuftsmedicine.org
Contact: Katina Robison, MD katina.robison@tuftsmedicine.org

Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Contact: Alysa St. Charles, MA    617-636-9897    alysa.st.charles@tuftsmedicine.org   
Principal Investigator: Rafael Gonzalez, MD         
Principal Investigator: Katina Robison, MD         
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Rafael Gonzalez, MD Tufts Medical Center
More Information
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Publications:

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT06035068    
Other Study ID Numbers: STUDY00004163
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vulvar Diseases
 Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases