Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

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

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

14 criteria

  • 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 trial?

13 criteria

  • 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
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

  • Iodine-131

    A radioactive form of iodine administered orally or intravenously for treating differentiated thyroid cancer (DTC), particularly in cases with metastatic spread. This radiopharmaceutical works by selectively accumulating in thyroid tissue and its metastases, delivering targeted radiation that destroys cancer cells while minimizing damage to surrounding healthy tissues. The medication belongs to the class of radiotherapeutic agents and has been a standard treatment in thyroid cancer management for decades, with dosing that can be either fixed or personalized based on PET imaging studies with Iodine-124 for optimal therapeutic effect.

  • Iodine-124

    A diagnostic radioactive isotope used in PET imaging studies for thyroid cancer patients, administered intravenously before treatment planning. This imaging agent helps physicians visualize thyroid cancer tissue and calculate precise radiation doses for subsequent Iodine-131 therapy. It belongs to the diagnostic radiopharmaceutical class and serves as an important tool in personalizing treatment approaches for patients with metastatic differentiated thyroid cancer, allowing for more accurate dosimetry-based therapy planning.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516273-80-00Protocol codeAIRC Id. 21939Estimated enrolment50 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).