In short
This article discusses a clinical trial investigating the use of Pertechnetate (99mTc) Sodium, along with indocyanine green (ICG), for sentinel node detection in patients with early-stage epithelial ovarian cancer. The study aims to evaluate the efficiency and precision of these tracers in identifying sentinel lymph nodes, which could potentially improve the staging and treatment of ovarian cancer.
At a glance
- Study Title
- Sentinel node detection with 99Tc albumin nanocolloid and indocianine green (ICG) in patients with epithelial ovarian cancer in early stages. Pilot study.
- Main Objective
- To evaluate the diagnostic efficiency of both tracers in sentinel lymph node detection
- Target Population
- Patients with early-stage epithelial ovarian cancer
- Primary Endpoint
- Global detection rate of sentinel lymph node in patients having received both tracers
- Key Secondary Endpoints
- Diagnostic precision, detection rates by tracer and technique, anatomical location of sentinel nodes, pathology ultrastaging evaluation
- Study Design
- Single-arm study where all patients receive both tracers
- Investigational Product
- Pertechnetate (99mTc) Sodium (Tekcis 2-50 GBq radionuclide generator)
- Maximum Daily Dose
- 400,000,000 Bq
- Route of Administration
- Injectable solution
What is PERTECHNETATE (99MTC) SODIUM?
PERTECHNETATE (99MTC) SODIUM, also known as Sodium pertechnetate (99mTc), is a radioactive substance used in medical imaging. It's classified as a radiopharmaceutical, which means it's a drug containing a radioactive isotope used for diagnostic or therapeutic purposes in nuclear medicine.
Medical Use in Early-Stage Ovarian Cancer
This substance is being studied for its potential use in detecting sentinel lymph nodes in patients with early-stage epithelial ovarian cancer. Epithelial ovarian cancer is a type of cancer that begins in the cells lining the ovaries. Early detection of cancer spread to lymph nodes is crucial for proper staging and treatment planning.
How Does It Work?
PERTECHNETATE (99MTC) SODIUM works as a tracer. When injected near the tumor site, it travels through the lymphatic system and collects in the sentinel lymph nodes - the first lymph nodes where cancer cells are likely to spread. Special cameras can then detect the radioactive signal, helping surgeons locate these important nodes.
How is It Administered?
The drug is administered as an injectable solution. It's typically injected near the tumor site before surgery. The maximum daily dose is 400,000,000 Bq (becquerels), which is a unit used to measure radioactivity.
Current Clinical Trial
A clinical trial is currently underway to evaluate the effectiveness of PERTECHNETATE (99MTC) SODIUM in sentinel node detection for early-stage ovarian cancer. The study aims to:
- Assess how well the tracer can detect sentinel lymph nodes
- Evaluate the precision of sentinel lymph node detection
- Study the lymphatic drainage patterns in ovarian cancer
- Compare the performance of different detection techniques
- Examine the anatomical distribution of sentinel lymph nodes
Who is Eligible for the Trial?
The trial is open to patients who meet specific criteria:
- Women with suspected or confirmed early-stage epithelial ovarian cancer
- No evidence of cancer spread to lymph nodes or distant sites on imaging
- Able to undergo surgery
- 18 years of age or older
- Not pregnant or breastfeeding
Potential Benefits
If successful, this technique could offer several benefits:
- More accurate staging of ovarian cancer
- Improved detection of small metastases in lymph nodes
- Potentially less extensive surgery if unnecessary lymph node removal can be avoided
- Better understanding of how ovarian cancer spreads through the lymphatic system
Precautions and Exclusions
Certain conditions may prevent participation in the trial:
- Advanced stage ovarian cancer (FIGO stage III or IV)
- History of vascular surgery or radiation therapy in the pelvic or para-aortic area
- Hypersensitivity to the active ingredient or iodine allergy
- Clinical hyperthyroidism or certain thyroid conditions
It's important to note that while this treatment shows promise, it's still under investigation. Patients should discuss all potential risks and benefits with their healthcare provider before considering participation in any clinical trial.