Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Sentinel Node Detection in Early-Stage Cervical Cancer Using Indocyanine Green Compared to 99mTc and Blue Dye

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying cervical cancer at stages I to IIA. The trial is investigating a new method for detecting sentinel lymph nodes, which are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. The study will compare the effectiveness of a fluorescent dye called indocyanine green with the current standard methods, which use a radioactive substance known as 99mTc and a blue dye. The purpose of the study is to evaluate how well these methods can detect sentinel lymph nodes during surgery.

Participants in the study will undergo a procedure where the sentinel lymph nodes are identified using the different dyes and substances. The trial will assess the ability of indocyanine green to detect these nodes compared to the traditional methods. This involves using a special imaging technique called near-infrared fluorescence imaging to see the fluorescent dye during the operation. The study will also look at how quickly the detection can be completed with each method and any side effects that might occur.

The trial aims to provide insights into the overall detection rates and the accuracy of the different methods. It will also consider factors like the cost-effectiveness of the procedures and patient satisfaction with the care received. The study is expected to run until the end of 2025, with recruitment starting in April 2024. The findings could help improve the way sentinel lymph nodes are detected in patients with early-stage cervical cancer, potentially leading to better treatment outcomes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the inclusion criteria, which include being 18 years or older, having a confirmed diagnosis of cervical cancer stage I-IIA, and planning for radical surgery including a sentinel lymph node (SLN) procedure.

  2. Step 2

    Preoperative preparation

    Before surgery, a tracer called 99mTc is used. This involves a scan called SPECT/CT to help locate the SLNs. This is part of the standard care.

  3. Step 3

    Surgical procedure

    During surgery, indocyanine green (ICG) is administered intracervically. This is a fluorescent dye that helps in identifying SLNs using near-infrared (NIR) fluorescence imaging.

    Additionally, a blue dye is used to assist in locating the SLNs. The goal is to compare the detection rate of SLNs using ICG with the standard method of 99mTc and blue dye.

  4. Step 4

    Postoperative evaluation

    The primary focus is on the bilateral detection rate of SLNs using ICG and NIR fluorescence compared to 99mTc and blue dye.

    Secondary evaluations include overall detection rate, sensitivity, false negative rate, and any adverse events related to the use of ICG, 99mTc, and blue dye.

  5. Step 5

    Patient feedback

    Patient satisfaction with the procedure and oncological care is assessed using a questionnaire. This helps in understanding the patient's perspective on the care received.

Who can join the trial?

5 criteria

  • Must be at least 18 years old and able to give permission to participate in the study.
  • Must have a confirmed diagnosis of a primary cancer in the cervix, which is the lower part of the uterus.
  • The cancer should be at an early stage, specifically stage IA1 to IB2 or IIA1, based on guidelines from 2018.
  • Must be planning to have a major surgery that includes a procedure to check the lymph nodes, which are small glands that help fight infection.
  • Only females can participate in this study.

Who cannot join the trial?

3 criteria

  • Patients who do not have **cervical cancer stage I-IIA** cannot participate. This means the cancer must be in an early stage, specifically stage I to IIA.
  • Only **female** patients are eligible for this study. Male patients cannot participate.
  • Patients who are considered part of a **vulnerable population** are not eligible. This typically refers to groups who may have additional risks or need special protection in research.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Indocyanine Green (ICG)

    is a fluorescent dye used during surgery to help doctors see certain tissues more clearly. In this trial, it is used with a special camera that detects near-infrared light to find sentinel lymph nodes in patients with early-stage cervical cancer.

  • 99mTc

    is a radioactive substance used in medical imaging. In this trial, it is injected before surgery and helps doctors locate sentinel lymph nodes using a special scan called SPECT/CT.

  • Blue Dye

    is a colored dye used during surgery to visually identify sentinel lymph nodes. It is injected near the tumor site and helps surgeons see the lymph nodes that need to be removed for examination.

What is already known about the treatment

Indocyanine Green – This medication is administered intravenously and is used in medical imaging procedures. It is currently being studied for its effectiveness in detecting sentinel lymph nodes in patients with early-stage cervical cancer. Indocyanine Green works by binding to plasma proteins and emitting fluorescence when exposed to near-infrared light, allowing for visualization of lymphatic structures. It is classified as a diagnostic agent and is being compared to traditional methods like 99mTc and blue dye in clinical trials.

Investigated diseases

Cervical Cancer Stage I-IIA – This is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus connecting to the vagina. In Stage I, the cancer is confined to the cervix, while in Stage IIA, it may have spread to the upper part of the vagina but not to the pelvic wall or lower part of the vagina. The disease progresses as cancer cells grow and potentially spread to nearby tissues. It is often detected through routine screening methods like Pap smears. Symptoms may include abnormal vaginal bleeding, pelvic pain, or pain during intercourse. Early stages may not present noticeable symptoms, making regular screenings important for detection.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-511966-36-00Estimated enrolment101 patientsSponsorUniversitair Medisch Centrum Utrecht

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.