In short
This article discusses the use of Sodium Iodide (123 I) in clinical trials for patients with advanced non-medullary thyroid cancer. The focus is on a study investigating the potential of digoxin to reinstate radioiodine uptake in patients whose cancer no longer responds to standard radioiodine therapy. We'll explore the trial's objectives, eligibility criteria, and potential outcomes for patients with this challenging form of thyroid cancer.
At a glance
- Study Title
- Digoxin for the Reinduction of Radioiodine Uptake in Metastatic or Locally Advanced Non-medullary Thyroid Carcinoma
- Primary Objective
- To study the effects of digoxin on reinstating radioiodine uptake in non-responsive thyroid cancer lesions
- Key Eligibility Criteria
- Adults with NMTC, previous thyroidectomy and RaI treatment, presence of RaI-refractory lesions
- Role of Sodium Iodide (123 I)
- Diagnostic tool to assess reinduction of radioiodine uptake
- Primary Endpoint
- Percentage of subjects with reinduction of RaI uptake in target lesions
- Secondary Endpoints
- Tumor response, biochemical response, toxicity assessment, quality of life
- Dosage of Sodium Iodide (123 I)
- Maximum daily dose: 148 MBq, Maximum total dose: 296 MBq
- Administration Route
- Intravenous injection
What is SODIUM IODIDE (123 I)?
SODIUM IODIDE (123 I) is a radioactive form of iodine used in medical imaging. It's also known by its brand name "Sodium Iodide (I123) Injection" and is classified as a diagnostic radiopharmaceutical. This substance is used to help doctors visualize certain parts of the body, particularly the thyroid gland.
Medical Use
The primary use of SODIUM IODIDE (123 I) is in the diagnosis and management of non-medullary thyroid carcinoma (NMTC), a type of thyroid cancer. Specifically, it's used in a procedure called radioiodine (RaI) scintigraphy, which helps doctors: Detect the presence of thyroid cancer Identify if the cancer has spread to other parts of the body (metastasis) Assess how well the cancer is responding to treatment
This diagnostic tool is particularly valuable for patients with advanced or metastatic NMTC, where it can help determine if the cancer cells are still able to absorb iodine, which is crucial for certain treatments.
Administration
SODIUM IODIDE (123 I) is administered as a solution for injection. It's typically given through an intravenous injection, which means it's injected directly into a vein. The dosage is measured in MBq (megabecquerels), which is a unit used to measure radioactivity. The maximum daily dose is typically around 148 MBq, with a maximum total dose of 296 MBq over a treatment period of up to 2 days.
Clinical Trial Information
A clinical trial (number 2022-500477-14-00) is currently exploring the use of SODIUM IODIDE (123 I) in combination with another drug called digoxin for patients with advanced non-medullary thyroid cancer. The main goals of this trial are: To study if digoxin can help reinduce radioiodine uptake in patients whose cancer has stopped responding to radioiodine therapy To assess the effects of radioiodine therapy on tumor progression after this reinduction To evaluate the safety of the digoxin treatment
Eligibility Criteria
To participate in this clinical trial, patients must meet certain criteria. Some key inclusion criteria are: Diagnosed with non-medullary thyroid carcinoma (NMTC) At least 18 years old Have undergone total thyroidectomy (complete removal of the thyroid gland) and at least one treatment with radioactive iodine Have local or metastatic disease that is radiologically proven Have at least one lesion that doesn't show significant uptake of radioactive iodine in previous scans
There are also several exclusion criteria, including certain medical conditions, medications, and recent treatments that might interfere with the study.
Potential Benefits and Risks
The potential benefits of using SODIUM IODIDE (123 I) in this context include: Improved detection and monitoring of thyroid cancer Possibility of making radioiodine therapy effective again in patients who have stopped responding to it Better understanding of how thyroid cancer responds to treatment
However, as with any medical procedure involving radiation, there are potential risks. These may include: Exposure to radiation, which should be carefully controlled Possible allergic reactions to the injection Interference with other medical tests or treatments It's important to discuss these potential risks and benefits with your healthcare provider.