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Completed

NCT Number: NCT03986437

A Prospective Study to Collect Images in Patients Treated With Iodine-131 as Part of a European Research Project in Radiation Protection.

This trial is a prospective, non-interventional, monocentric study aiming to collect standard of care imaging of patients treated with Iodine-131 for the determination of dosimetric studies.

Data from this study will be collected as part of an European research project called MEDIRAD.

The overall objectives of this project are to enhance the scientific bases and clinical practice of radiation protection in the medical field, and more specifically to develop and implement the tools necessary to establish the range of absorbed doses delivered to healthy organs in patients undergoing thyroid ablation and the threshold absorbed dose required for thyroid ablation. This will enable patient specific treatment planning that will minimize risk to the patient while ensuring a successful outcome and will facilitate development of a large scale epidemiological study of the effect of low absorbed doses from irradiation of normal organs with internal sources of radionuclides.

Patients will be followed as part of their standard of care. Imaging (SPECT/CT (Single Photon Emission Computed Tomography-Computerized Tomography) and Whole Body scintigraphy) performed at 48 hours post Iodine-131 treatment will be collected. Measures of external gamma radiation will also be collected in the European database.

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Key information

Conditions

Differentiated Thyroid Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IUCT-O

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with differentiated thyroid cancer (papillary or follicular) stage T1b, T2, T3A, Nx-N0-N1, M0 (according to AJCC 8th edition, 2017) of intermediate risk of recurrence (according to 2015 ATA Risk Stratification System)
  • Patient is eligible to receive a therapeutic activity of 3.7 GBq of I-131 after total thyroidectomy or completion thyroidectomy
  • Age ≥ 18 years old
  • Patient affiliated to the French social security system
  • Patient who has received an informed consent for the study

Exclusion criteria

  • Patient who has received an external radiotherapy within 6 weeks prior to I-131 treatment
  • Patient who has received a systemic chemotherapy within 6 weeks prior to I-131 treatment
  • History of treatment with I-131
  • Pregnant or breastfeeding women
  • Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
  • Patient protected by law

Treatment and study plan

Primary outcomes

  1. Number of patients with interpretable images

    Time frame: 1 week per patient

Secondary outcomes

  1. Rate of radiation dose

    Time frame: 1 week per patient

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: MEDIRAD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2019
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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