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Sodium Iodide (123 I)

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.

Table of Contents

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[1]. 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[1]. 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[1].

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[1]. 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[1].

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[1]. The main goals of this trial are:

  1. To study if digoxin can help reinduce radioiodine uptake in patients whose cancer has stopped responding to radioiodine therapy
  2. To assess the effects of radioiodine therapy on tumor progression after this reinduction
  3. To evaluate the safety of the digoxin treatment

Eligibility Criteria

To participate in this clinical trial, patients must meet certain criteria[1]. 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[1].

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[1].

Aspect Details
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

FAQ

  • What is the purpose of using Sodium Iodide (123 I) in this clinical trial? Sodium Iodide (123 I) is used as a diagnostic tool in this trial. It helps to assess whether the treatment with digoxin has successfully reinstated radioiodine uptake in thyroid cancer lesions that previously didn't respond to radioiodine therapy.
  • Who is eligible to participate in this clinical trial? Eligible participants are adults (18 years or older) diagnosed with non-medullary thyroid cancer who have undergone total thyroidectomy and at least one radioiodine treatment. They must have local or metastatic disease that no longer responds to radioiodine therapy.
  • What is the main objective of the trial? The main objective is to study the effects of digoxin in reinstating radioiodine uptake in patients with advanced non-medullary thyroid cancer whose tumors no longer accumulate sufficient radioiodine.
  • How is the effectiveness of the treatment measured? The effectiveness is primarily measured by assessing the number of patients who show renewed radioiodine uptake in their tumors using radioiodine scintigraphy. Secondary measures include tumor response according to RECIST criteria and changes in thyroglobulin levels.
  • Are there any specific exclusion criteria for the trial? Yes, exclusion criteria include contraindications to digoxin (such as kidney disease or cardiac arrhythmias), rapidly progressing disease, use of certain medications that interfere with digoxin, pregnancy or breastfeeding, and recent radiation therapy or chemotherapy.

Ongoing Clinical Trials on Sodium Iodide (123 I)

  • Study on Digoxin and Sodium Iodide (123 I) for Patients with Advanced Non-Medullary Thyroid Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Non-medullary thyroid carcinoma (NMTC): A type of thyroid cancer that originates from the follicular cells of the thyroid gland, as opposed to medullary thyroid cancer which arises from C cells.
  • Radioiodine (RaI): A radioactive form of iodine used in the treatment and diagnosis of thyroid conditions. In this context, it refers to iodine-131 used for therapy.
  • Sodium Iodide (123 I): A radioactive isotope of iodine used for diagnostic imaging in nuclear medicine, particularly for thyroid scans.
  • Digoxin: A medication typically used to treat various heart conditions, being studied in this trial for its potential to reinstate radioiodine uptake in thyroid cancer cells.
  • Scintigraphy: An imaging technique used in nuclear medicine that produces two-dimensional images of the distribution of radioactivity in tissues.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors, a set of rules used to assess the change in size of tumors during cancer treatment.
  • Thyroglobulin (TG): A protein produced by the thyroid gland, often used as a tumor marker in thyroid cancer patients after thyroidectomy.
  • Metastatic disease: Cancer that has spread from its original site to other parts of the body.
  • Radioiodine-refractory: Describing thyroid cancer that no longer responds to or takes up radioactive iodine treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-digoxin-and-sodium-iodide-123-i-for-patients-with-advanced-non-medullary-thyroid-cancer/