Study on [18F]Tetrafluoroborate PET/CT for Detecting Thyroid Cancer in Patients with Differentiated Thyroid Cancer

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What is this study about?

This clinical trial is focused on studying Differentiated Thyroid Cancer, a type of cancer that affects the thyroid gland, which is located in the neck and produces hormones that regulate metabolism. The study will use a special imaging technique called [18F]Tetrafluoroborate PET/CT. This involves a solution for injection that contains a substance known as Tetrafluoroborate Ion F-18, which helps to create detailed images of the thyroid and surrounding areas.

The purpose of the study is to determine the best time to take images using the [18F]Tetrafluoroborate PET/CT and to see how well it can detect cancer that has spread to nearby lymph nodes before surgery. It will also assess how useful this imaging method is in predicting how patients with persistent or returning thyroid cancer will respond to a common treatment called radioiodine therapy. The study will involve patients who have been newly diagnosed with differentiated thyroid cancer and those who are undergoing treatment.

Throughout the study, participants will receive the [18F]Tetrafluoroborate injection and undergo PET/CT scans. These scans will help doctors see how the cancer is behaving and whether it has spread. The study will also look at how the substance is absorbed in normal thyroid tissue, the primary tumor, and any areas where the cancer has spread. This information could help improve the way thyroid cancer is diagnosed and treated in the future.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate in the study after understanding all the details and potential risks involved.

You must be at least 18 years old and have a specific health status, known as ECOG status grade 0-2, which indicates your level of functioning in terms of daily activities.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of differentiated thyroid cancer and any related conditions.

You will be grouped based on your condition: either newly diagnosed with lymph node metastases or referred for a specific therapy known as 131I therapy.

3 administration of the solution

You will receive an intravenous injection of a solution called [18F]Tetrafluoroborate. This is a special type of imaging agent used to help visualize certain areas in your body during scans.

The injection is part of a procedure called PET/CT, which combines two types of imaging to provide detailed pictures of your body.

4 imaging procedure

After the injection, you will undergo a PET/CT scan. This scan helps in detecting any cancerous areas and assessing the spread of the disease.

The main goal is to determine the best time to capture images and to evaluate the presence of any metastatic lymph nodes, which are areas where cancer may have spread.

5 follow-up assessments

Follow-up assessments will be conducted to monitor your response to the imaging and any subsequent treatments.

These assessments may include additional scans and tests that are part of your regular clinical care, such as ultrasonography and pathology.

6 end of participation

Your participation in the study will conclude after all necessary data has been collected and analyzed.

The study is expected to continue until December 2027, but your individual participation may end sooner depending on your specific treatment plan and response.

Who Can Join the Study?

Patients must have differentiated thyroid cancer.
Group 1: Patients with newly diagnosed differentiated thyroid cancer and confirmed cancer spread to lymph nodes, who are scheduled for surgery.
Group 2: Patients with differentiated thyroid cancer who are scheduled for 131I therapy (a type of radioactive iodine treatment).
Patients must provide written consent to participate in the study.
Patients must be 18 years old or older.
Patients must have an ECOG status of grade 0-2, which means they are fully active or have some limitations but can still take care of themselves.

Who Cannot Join the Study?

Patients who do not have Differentiated Thyroid Cancer cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Ehswafn Uoxwmgngldyi Mpjkogq Ckjiwuj Rzsmdufqn (kehibfb Mix	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.04.2025

Trial locations

[18F]Tetrafluoroborate is a special type of imaging agent used in a PET/CT scan. This medication helps doctors see certain types of thyroid cancer more clearly. It works by highlighting cancer cells in the body, making them easier to detect on the scan. This can help doctors find cancer that might have spread to other parts of the body, like the lymph nodes, and also helps in assessing how well the cancer is responding to treatment. This imaging agent is particularly useful for patients with a type of thyroid cancer called differentiated thyroid cancer.

Investigated diseases:

Thyroid cancer

Differentiated Thyroid Cancer – Differentiated thyroid cancer is a type of cancer that originates from the thyroid gland, which is located in the neck and produces hormones that regulate metabolism. This cancer is characterized by the abnormal growth of cells that resemble normal thyroid tissue. It typically progresses slowly and can spread to nearby lymph nodes and, in some cases, to distant parts of the body. The disease often begins as a small nodule in the thyroid gland, which may grow over time. As it progresses, it can cause symptoms such as a lump in the neck, changes in voice, or difficulty swallowing. The progression of the disease can vary, with some cases remaining stable for years, while others may become more aggressive.

Trial ID:

2024-516025-30-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on [18F]Tetrafluoroborate PET/CT for Detecting Thyroid Cancer in Patients with Differentiated Thyroid Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?