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Study on Sentinel Lymph Node Technique in Early-Stage Ovarian Cancer Using Pertechnetate (99mTc) Sodium, Human Serum Albumin, and Indocyanine Green

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What is this trial about?

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

This clinical trial aims to validate the sentinel lymph node technique in early-stage ovarian cancer. Ovarian cancer is a malignant tumor that develops in the ovaries, which are part of the female reproductive system. The study focuses on patients with epithelial ovarian tumors in apparent early stages (FIGO I-II). A sentinel lymph node is the first lymph node to which cancer cells are likely to spread from the primary tumor.

The purpose of the study is to determine how accurately the sentinel lymph node technique can predict whether cancer has spread to lymph nodes. This will be compared with the current standard approach of pelvic/aortic lymphadenectomy (surgical removal of lymph nodes in the pelvic and aortic regions). During the study, participants will undergo a surgical procedure where a tracer substance is injected near the tumor to identify the sentinel lymph nodes, which are then removed and examined for cancer cells.

This research may help determine if the sentinel lymph node technique can provide reliable information about cancer spread while potentially allowing for less extensive surgery than complete lymphadenectomy. The technique could potentially reduce surgical complications while maintaining accurate cancer staging information.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Confirmation of Eligibility and Surgical Planning
Your doctor has determined you are eligible for this study based on your diagnosis of an ovarian tumor in early stage (FIGO I-II). This means the cancer appears to be confined to the ovaries or nearby areas without spreading widely.
A surgery for staging will be planned. This surgery aims to determine how far the cancer has spread, which is essential for treatment planning.
Step 2
Day of Surgery - Tracer Injection
On the day of your surgery, you will receive injections of special substances called tracers that help identify sentinel lymph nodes (the first lymph nodes where cancer cells might spread).
The tracers used may include pertechnetate (99mTc) sodium (a radioactive substance), human serum albumin (a protein naturally found in blood), and/or indocyanine green (a dye that can be seen with special cameras).
These tracers will be injected near your tumor. The injection site will depend on where your tumor is located in the ovary.
Step 3
Sentinel Lymph Node Detection
After the tracer injection, there will be a waiting period for the tracer to travel through your lymphatic system to the sentinel lymph nodes.
During surgery, your doctor will use special detection methods to identify these sentinel lymph nodes that have absorbed the tracers.
The sentinel lymph nodes will be removed for examination.
Step 4
Standard Lymphadenectomy
After the sentinel lymph nodes are identified and removed, you will also undergo a standard lymphadenectomy (removal of additional lymph nodes from the pelvic and aortic regions).
This is the current standard procedure for ovarian cancer staging and will serve as the comparison for the sentinel lymph node technique.
Step 5
Completion of Staging Surgery
The rest of your staging surgery will be completed according to standard protocols for ovarian cancer.
This typically includes removal of the affected ovary and possibly other reproductive organs, depending on your specific situation and the extent of your cancer.
Step 6
Laboratory Analysis
All removed tissue, including the sentinel lymph nodes and other lymph nodes, will be sent to the laboratory for detailed examination.
The sentinel lymph nodes will undergo ultrastaging, which is a more detailed examination than standard pathology to look for even tiny cancer deposits.
Step 7
Recovery and Follow-up
You will recover from surgery according to standard protocols.
Your doctor will discuss the results of your surgery and pathology findings during your follow-up appointments.
Your further treatment will be planned based on these results, following standard care guidelines for ovarian cancer.

Who can join the trial?

4 criteria

You must sign an informed consent before any procedure related to the clinical trial is performed.
You must be a female who is 18 years of age or older when joining the study.
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You must have one of the following conditions:
- A confirmed diagnosis of malignant ovarian tumor (cancer in the ovary) that has been diagnosed through tissue examination, in an early stage (FIGO stages I-II, meaning the cancer appears to be limited to the ovaries or pelvis), and you are scheduled for staging surgery (a procedure to determine how far the cancer has spread).
- OR, you have a suspected malignant ovarian tumor in early stage that requires exploratory surgery and a biopsy (tissue sample). If the biopsy confirms cancer, you will then undergo staging surgery.

Who cannot join the trial?

10 criteria

If you are not diagnosed with ovarian cancer in its early stages (I or II).
If you've already had a major surgery on your ovaries or fallopian tubes before.
If you've already had a lymph node removal surgery in your pelvic or lower back area.
If you are allergic to blue dye or a substance called indocyanine green (a special dye used during the procedure).
If you have serious heart or liver problems.
If you're pregnant or breastfeeding.
If you are unable to provide informed consent (understand and agree to the study procedures).
If you have metastases (cancer that has spread) beyond your reproductive organs or to distant parts of your body.
If you've had chemotherapy treatment before surgery.
If you've had radiation therapy to your pelvis or abdomen before.

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Verified sites

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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
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Hospital Clinic De Barcelona
Barcelona, Spain
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Hospital General Universitario Gregorio Maranon
Madrid, Spain

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Investigated drugs

This clinical trial focuses on a procedure rather than medications. It involves: Sentinel Lymph Node Technique - This is a surgical procedure where doctors identify and remove the first lymph node(s) to which cancer cells are likely to spread from the original tumor. A special dye or radioactive substance is injected near the tumor, which flows to the sentinel nodes, helping surgeons locate them. This technique aims to determine if cancer has spread beyond the original site while removing fewer lymph nodes than traditional approaches. Lymphadenectomy - This is the standard surgical procedure that involves removing multiple lymph nodes from the pelvic and aortic regions to check for cancer spread. This more extensive surgery is being used as the comparison (Gold Standard) to validate the effectiveness of the sentinel lymph node technique.

What is already known about the treatment

Sentinel Lymph Node Technique – This is not a medication but a surgical procedure used to identify the first lymph node(s) where cancer cells are most likely to spread from a primary tumor. In the SENTOV II trial for early-stage ovarian cancer, a tracer substance is injected near the tumor, which travels through lymphatic vessels to the sentinel node. Surgeons then remove this node for examination, potentially avoiding more extensive lymph node removal if no cancer is found. The technique aims to reduce surgical complications while maintaining accurate cancer staging. This approach is being validated against the current standard of complete pelvic/aortic lymphadenectomy to determine its reliability in detecting lymph node metastases in ovarian cancer patients.

Investigated diseases

Ovarian cancer – A malignancy that begins in the ovaries, which are the female reproductive organs that produce eggs. The disease typically starts when cells in the ovaries develop mutations and grow uncontrollably, forming a tumor. As ovarian cancer progresses, cancer cells can spread (metastasize) to other parts of the pelvis, abdomen, and beyond through direct extension or via the lymphatic system. The disease often develops silently in its early stages, gradually causing symptoms like abdominal swelling, pelvic discomfort, and changes in bowel habits as tumors grow. Different types of ovarian cancer exist, including epithelial (most common), germ cell, and stromal tumors, each developing from different cell types within the ovary. The disease is classified into stages based on how far it has spread, with higher stages indicating more extensive disease.