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Study on Sentinel Node Detection Using Technetium-99m and Indocyanine Green in Patients with Early-Stage Ovarian Cancer

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What is this trial about?

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

This clinical trial focuses on patients with epithelial ovarian cancer in its early stages. The study aims to evaluate the effectiveness of two substances in detecting sentinel lymph nodes, which are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. The substances being tested are 99mTc albumin nanocolloid and indocyanine green (ICG). These substances are used to help doctors see the lymph nodes more clearly during surgery.

Participants in the study will receive an injection of these substances, which will help in identifying the sentinel lymph nodes. The study will assess how well these substances work in detecting the lymph nodes and whether they provide accurate results. The trial will also look at the location of the sentinel lymph nodes and any potential complications that might arise from using these substances.

The purpose of this study is to improve the diagnostic process for patients with early-stage epithelial ovarian cancer by using these substances to better identify sentinel lymph nodes. This could potentially lead to more accurate staging of the cancer and help in planning the most effective treatment. The study is expected to continue until 2026, with the aim of gathering comprehensive data on the effectiveness and safety of these diagnostic agents.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have a confirmed diagnosis of epithelial ovarian cancer in early stages or an adnexal mass with high suspicion of malignancy.
The patient must sign an informed consent form. Women with childbearing potential must agree to use highly effective contraceptive methods until the end of the study.
Step 2
Preoperative evaluation
The patient undergoes preoperative imaging techniques to ensure there is no retroperitoneal ganglionary affectation or metastatic disease.
Step 3
Administration of tracers
The patient receives an injection of 99mTc albumin nanocolloid and indocyanine green (ICG) as tracers for sentinel lymph node detection.
These substances are administered as an injectable solution.
Step 4
Surgical procedure
During surgery, the sentinel lymph nodes are identified using the tracers.
The procedure aims to evaluate the diagnostic efficiency of the tracers in detecting sentinel lymph nodes.
Step 5
Post-operative evaluation
The detection rate of sentinel lymph nodes is assessed, including the rate of false negatives.
The anatomical location of sentinel lymph nodes is evaluated, and the concordance between the tracers is assessed.
Step 6
Follow-up
The patient is monitored for any surgical or post-operative complications that may be directly or indirectly associated with the use of the tracers.
The study is estimated to conclude by October 2, 2026.

Who can join the trial?

4 criteria

Patients must have an adnexal mass (a growth in the area of the ovaries) with a high suspicion of being cancerous, and they will undergo a biopsy during surgery. Alternatively, patients can have already been diagnosed with early-stage epithelial ovarian cancer in a previous surgery, confirmed by a pathology report, and need complete staging.
There should be no signs of cancer spreading to the retroperitoneal ganglions (lymph nodes located behind the abdominal cavity) or any other parts of the body, as shown by imaging tests done before surgery.
The patient or a responsible family member must sign an informed consent form, which is a document that explains the study and confirms their agreement to participate.
Women who can have children must agree to use highly effective birth control methods, such as a partner who has had a vasectomy or practicing sexual abstinence, until the study is completed.

Who cannot join the trial?

2 criteria

Only women can participate in this study. Men are not eligible.
The study is not open to vulnerable populations, which means people who might need special protection or care.

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Responsive
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Barcelona, Spain

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Investigated drugs

99Tc Albumin Nanocolloid
is a radioactive tracer used in medical imaging. In this trial, it helps doctors locate sentinel lymph nodes in patients with early-stage epithelial ovarian cancer. By identifying these lymph nodes, doctors can better understand the spread of cancer and plan appropriate treatment.
Indocyanine Green (ICG)
is a dye used in medical imaging. In this trial, it is used alongside the radioactive tracer to help visualize sentinel lymph nodes in patients with early-stage epithelial ovarian cancer. This helps doctors assess the spread of cancer and make informed decisions about treatment.

What is already known about the treatment

Indocyanine Green (ICG)
This medication is administered intravenously and is used in medical imaging to help visualize certain structures in the body. It is currently being studied in clinical trials for its effectiveness in detecting sentinel lymph nodes in patients with early-stage epithelial ovarian cancer. The main therapeutic indication is its use as a diagnostic agent to assist in identifying lymph nodes that may be affected by cancer. At the molecular level, ICG works by binding to plasma proteins and emitting fluorescence when exposed to near-infrared light, allowing for enhanced imaging. It is classified as a diagnostic dye.
Technetium-99m Albumin Nanocolloid
This medication is administered via injection and is used in nuclear medicine imaging. It is being evaluated in clinical trials for its role in detecting sentinel lymph nodes in early-stage epithelial ovarian cancer. The primary therapeutic indication is its use as a radiopharmaceutical agent to help identify lymph nodes that may be involved in cancer spread. At the molecular level, Technetium-99m binds to albumin nanocolloids, which then localize in lymphatic tissue, allowing for imaging with a gamma camera. It is classified as a radiopharmaceutical diagnostic agent.

Investigated diseases

Epithelial Ovarian Cancer in Early Stages – This is a type of cancer that begins in the layer of cells covering the ovary, known as the epithelium. In its early stages, the cancer is confined to the ovaries and may not cause noticeable symptoms. As it progresses, it can lead to abdominal discomfort, bloating, or changes in bowel habits. The disease may spread to nearby pelvic organs or lymph nodes if not detected early. Early-stage detection is crucial for managing the disease effectively. The focus is often on understanding the spread to sentinel lymph nodes, which are the first nodes to which cancer cells are likely to spread.