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Vulva CancerNCT06035068

SLN Mapping and ICG Dye for Vulvar Cancer

An observational study of Vulva Cancer, run by Tufts Medical Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Vulva Cancer
What is being tested?
Indocyanine green
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Nov 2025to Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: 10 participants fitting the above criteria at Tufts Medical Center

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rafael Gonzalez, MD contact

617-636-6058

rafael.gonzalez@tuftsmedicine.org

Katina Robison, MD contact

katina.robison@tuftsmedicine.org

United States1 site

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Alysa St. Charles, MA, 617-636-9897, alysa.st.charles@tuftsmedicine.org

    Rafael Gonzalez, MD

Other trials in United States

About this study

Official title: Sentinel Lymph Node Mapping and Detection With Indocyanine Green and Spy-Phi Handheld Camera Technology in Early-Stage Vulvar Cancer (PILOT)

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.

Conditions
Vulva Cancer
Being tested
Indocyanine green
Medical subject headings
Vulvar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine greenDrug

    Also called ICG dye

    Indocyanine green (ICG) is a fluorescent dye that has been used for the imaging of cancers in the body for more than 30 years.

Study groups in NCT06035068
Study groupRoleWhat they receive
Combined ICG dye and blue tracer dyeThis 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.
Receives: Drug: Indocyanine green

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection Rate of SLNs using ICG Dye vs Blue Dye at Patient Level

    • 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.

    Measured: Data collection at time of surgery

  2. Clustered Analysis at the Hemi-Pelvis Level

    • 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.

    Measured: Data collection at time of surgery

  3. 3. Difference in SLNs Detected in Blue vs Green Dye when Data is Clustered at Hemi-Pelvis Level

    • 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

    Measured: Data collection at time of surgery

Secondary outcomes (1)

  1. Sensitivity, Specificity, and Negative Predictive Value of ICG Dye vs Standard Blue Dye

    • 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).

    Measured: Data collection at time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start1 Nov 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06035068
Sponsor's protocol ID
STUDY00004163
Status last verified
Sep 2025
First submitted
6 Sep 2023
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Te Grootenhuis NC, van der Zee AG, van Doorn HC, van der Velden J, Vergote I, Zanagnolo V, Baldwin PJ, Gaarenstroom KN, van Dorst EB, Trum JW, Slangen BF, Runnebaum IB, Tamussino K, Hermans RH, Provencher DM, de Bock GH, de Hullu JA, Oonk MH. Sentinel nodes in vulvar cancer: Long-term follow-up of the GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) I. Gynecol Oncol. 2016 Jan;140(1):8-14. doi: 10.1016/j.ygyno.2015.09.077. Epub 2015 Sep 30.

    PubMed 26428940

  • Covens A, Vella ET, Kennedy EB, Reade CJ, Jimenez W, Le T. Sentinel lymph node biopsy in vulvar cancer: Systematic review, meta-analysis and guideline recommendations. Gynecol Oncol. 2015 May;137(2):351-61. doi: 10.1016/j.ygyno.2015.02.014. Epub 2015 Feb 20.

    PubMed 25703673

  • Hutteman M, van der Vorst JR, Gaarenstroom KN, Peters AA, Mieog JS, Schaafsma BE, Lowik CW, Frangioni JV, van de Velde CJ, Vahrmeijer AL. Optimization of near-infrared fluorescent sentinel lymph node mapping for vulvar cancer. Am J Obstet Gynecol. 2012 Jan;206(1):89.e1-5. doi: 10.1016/j.ajog.2011.07.039. Epub 2011 Jul 30.

    PubMed 21963099

  • Crane LM, Themelis G, Arts HJ, Buddingh KT, Brouwers AH, Ntziachristos V, van Dam GM, van der Zee AG. Intraoperative near-infrared fluorescence imaging for sentinel lymph node detection in vulvar cancer: first clinical results. Gynecol Oncol. 2011 Feb;120(2):291-5. doi: 10.1016/j.ygyno.2010.10.009. Epub 2010 Nov 6.

    PubMed 21056907

Questions about this trial

What is this clinical trial studying?

An observational study of Vulva Cancer, run by Tufts Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rafael Gonzalez, MD (617-636-6058, rafael.gonzalez@tuftsmedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection Rate of SLNs using ICG Dye vs Blue Dye at Patient Level (time frame: Data collection at time of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06035068, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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