Evaluation of personalized Iodine-131 therapy using PET imaging in patients with metastatic thyroid cancer

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What is this study about?

This study focuses on treating metastatic differentiated thyroid cancer (DTC) that has spread to other parts of the body. The treatment involves using radioactive iodine, specifically sodium iodide (I-131), which is given as an oral capsule to target and treat thyroid cancer cells that have spread throughout the body.

The purpose of this research is to determine if personalizing the dose of radioactive iodine treatment based on detailed imaging studies can improve treatment effectiveness compared to using standard fixed doses. The study uses special imaging techniques called PET/CT scans with a different form of radioactive iodine (I-124) to help determine the optimal treatment dose for each patient.

During the study, participants may receive up to two treatments with radioactive iodine. The effectiveness of the treatment will be evaluated using various imaging techniques and blood tests to measure thyroid-specific markers. The study also aims to understand how genetic changes in the cancer and certain biological markers may affect how well the treatment works.

1 Initial evaluation

A medical evaluation will confirm your eligibility for the study based on your thyroid cancer diagnosis and presence of soft-tissue metastasis

Laboratory tests will check your blood counts, including hemoglobin (must be above 10 g/dL), white blood cells (must be above 3500/uL), and platelets (must be above 100,000/uL)

Your kidney function will be assessed through creatinine test (must be 2 mg/dL or lower)

2 Pre-treatment imaging

You will undergo a PET/CT scan using a special form of iodine (124I) to determine the optimal treatment dose

Additional imaging may include tests to measure glucose metabolism in your body

3 Treatment phase

Based on the imaging results, you will receive personalized treatment with radioactive iodine (131I)

The medication will be given as a hard capsule that you will take by mouth

You may receive up to two treatment sessions

4 Follow-up evaluations

Your response to treatment will be evaluated 6 months after the final treatment

Evaluation will include several types of scans: PET/CT with both radioactive iodine and glucose-based tracers

Blood tests will measure your thyroglobulin levels

Your overall response will be assessed using standard measurement criteria (RECIST)

5 Safety monitoring

Throughout the study, you will be monitored for any side effects from the treatment

Regular blood tests will continue to check your blood counts and kidney function

Who Can Join the Study?

Patient must have a confirmed tissue diagnosis of differentiated thyroid cancer (DTC) through examination of tissue samples
Must have at least one soft-tissue metastasis (cancer spread to other parts of the body) that cannot be treated with surgery and has not been previously treated
Must have good physical function, being able to perform daily activities with minimal assistance (ECOG performance status of 0 or 1)
Must be 18 years or older
Must have a life expectancy greater than 6 months
Women who can become pregnant must:
- Have a negative pregnancy test before starting the study
- Use birth control during the study and for 6 months after treatment ends
Must have adequate blood and kidney function, including:
- Hemoglobin above 10 g/dL (a protein that carries oxygen in blood)
- White blood cells (WBC) above 3500/uL (cells that fight infection)
- Neutrophils above 50% (a type of white blood cell)
- Platelets (PLT) above 100,000/uL (cells that help blood clot)
- Albumin at least 2.5 g/dL (a protein made by the liver)
- Creatinine no higher than 2 mg/dL (a measure of kidney function)
Must sign an informed consent form

Who Cannot Join the Study?

Age below 18 years or above 75 years
Pregnant women or women who are breastfeeding
Patients with severe kidney problems (as this may affect how the body processes the treatment)
Patients with severe bone marrow problems (conditions affecting blood cell production)
Those who have had chemotherapy or radiation therapy in the last 4 weeks
Patients who cannot follow radiation safety procedures
Those with serious heart conditions
Patients who have participated in another clinical trial within the past 30 days
People with known allergies to iodine-based substances
Patients who cannot provide informed consent
Those with severe mental health conditions that could interfere with following study procedures
Patients with other active cancers (except for non-melanoma skin cancer)
Those unable to comply with follow-up visits and study requirements

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
IRCCS Ospedale Sacro Cuore Don Calabria	Negrar di Valpolicella	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	14.07.2021

Trial locations

Investigated drugs:

Sodium Iodide (131I)

Iodine-131 (I-131) is a radioactive form of iodine used to treat thyroid cancer. It is taken as a capsule or liquid and works by targeting and destroying thyroid cancer cells that have spread to other parts of the body. The thyroid naturally absorbs iodine, which makes this treatment particularly effective for thyroid cancer.

Iodine-124 (I-124) is another radioactive form of iodine used for PET imaging. It helps doctors see where thyroid cancer cells are in the body and how well they might respond to treatment. This imaging helps determine the most effective dose of I-131 treatment for each patient.

Both treatments work together as part of a personalized approach to treating metastatic thyroid cancer, where I-124 PET scanning helps guide the dosing of I-131 therapy.

Differentiated Thyroid Cancer (DTC) – A type of thyroid cancer that develops from follicular cells in the thyroid gland. The cancer cells in DTC maintain some normal thyroid cell features and can absorb iodine. When the cancer spreads beyond the thyroid to other parts of the body, it is called metastatic DTC. The disease typically develops slowly and can spread to soft tissues and bones. The cancer cells continue to produce thyroid hormones and proteins, which can be measured in blood tests.

Trial ID:

2024-516273-80-00

Protocol code:

AIRC Id. 21939

Trial Phase:

Therapeutic exploratory (Phase II)

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Evaluation of personalized Iodine-131 therapy using PET imaging in patients with metastatic thyroid cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?