New imaging test could spare thyroid cancer patients unnecessary radiation
NCT ID NCT01704586
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using I-124 PET/CT scans can help doctors decide which thyroid cancer patients truly need radioiodine ablation therapy. About 340 adults with newly diagnosed differentiated thyroid cancer will be assigned to either standard care or I-124-guided care. The goal is to see if the imaging approach can safely reduce unnecessary radiation exposure and improve quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radioiodine I-131 and I-124
- What this could lead to
- If successful, this approach could reduce unnecessary radiation exposure and improve quality of life for low-risk thyroid cancer patients by personalizing treatment decisions.
- What could go wrong
- This is an observational study without randomization, so results may not be definitive. The long-term benefits and risks compared to standard care remain uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 340 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2015
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria common for all study subjects prior to randomisation: * Histologically confirmed new diagnosis of DTC (including Hürthle-cell carcinoma) * Age 18-80 years * Performance Status of 0-2 * Tumor stage T1b to T4 with the possibility of lymph node involvement and distant metastasis according to the \[TNM\] staging system * One- or two stage thyroidectomy, with or without central lymph node dissection * Patient´s written informed consent * Ability to comply with the protocol procedures Exclusion criteria for all study subjects prior to randomisation: * Anaplastic or medullary carcinoma * History of prior malignancy within the past 5 years with limited life-time expectancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years. * Positive pregnancy test or breast feeding * Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. * Recent iodine contamination After Randomisation I-124 arm: A: Inclusion criteria for no remnant ablation (low risk DTC): * Stage I (according to AJCC, ref. 1,33) papillary or follicular carcinoma with the possibility of lymph node involvement but no distant metastasis and no microscopical residual disease (Patient age \<45y: any T, any N, M0; Patient age 45y or older: T1, N0, M0) * I-124 uptake only in thyroid bed * Absence of aggressive malignant histologic subtypes, including tall-cell, insular, poorly differentiated and diffuse sclerosing thyroid cancer B: Inclusion criteria for remnant ablation (high risk DTC): * All other \[TNM\] stages (stage II to stage IV C) * Presence of aggressive malignant histologic subtypes, including tall-cell, insular, poorly differentiated and diffuse sclerosing thyroid cancer * I-124 uptake in and outside thyroid bed Standard arm: -Standard I-131 ablation concept as defined for all T1b to T4 subjects.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinic of Nuclear Medicine, University Clinic Essen
Essen, 45122, Germany
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University Clinic Würzburg
Würzburg, 97080, Germany
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