New imaging study aims to personalize thyroid cancer radiation doses
NCT ID NCT03841617
First seen Jun 24, 2026 · Last updated Sep 10, 2026 · Updated 13 times
Summary
This study tests two ways of preparing people with advanced thyroid cancer for a special PET scan that uses a radioactive form of iodine (I-124). The goal is to see which preparation method gives better information for calculating the right dose of radiation therapy. Thirty participants will be followed for five years to see how well the predicted doses match the actual response to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- I-124 (radioactive iodine for imaging)
- What this could lead to
- If successful, this study could help doctors choose the best way to prepare patients for radioactive iodine therapy, potentially making treatment more effective and safer.
- What could go wrong
- This is a small, early-phase study (30 people) focused on imaging, not treatment outcomes. The results may not lead to changes in standard care.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2019
- Expected to finish
-
Nov 2035
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 90 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Patients with established thyroid cancer diagnosis based on the pathology report reviewed at the National Institutes of Health, who: * underwent total thyroidectomy plus or minus neck lymph node dissection as clinically indicated, * are presenting with known per structural imaging (US neck, CT or MRI neck/chest/abdomen/pelvis) persistent/recurrent disease either locally advanced or presenting with distant metastases; or * are presenting with suspected persistent/recurrent locoregional or distant metastases based on the high risk features such as advanced tumor per pathology report (tumor size \>4 cm, exrathyroidal extension, higher risk pathology such as tall cell, columnar cell, poorly differentiated variant, follicular thyroid cancer with gross vascular invasion, positive margins after the surgery, bulky lymphadenopathy in the central and/or lateral neck), detectable/increasing baseline/suppressed thyroglobulin (Tg) level or detectable/increasing anti-Tg antibody titers if anti-Tg antibodies are present. * are either RAI -naive or requiring repeated RAI therapy for locally advanced disease or distant metastases or underwent therapy with BRAF inhibitor (dabrafenib or vemurafenib\*) or selumetinib\*\* for at least 4 weeks that may re-induce RAI uptake. * Underwent imaging with either a CT or MRI of the brain and spine with gadolinium contrast to screen for the brain/spine metastases. * Age greater than or equal to 18 years of age. * 24 hour urine iodine excretion of less than or equal to 150 micro grams/24 hour. * BRAF inhibitors are recommended by 2021 NCCN guidelines as one of the management options for BRAF mutant tumors(13,14) * Selumetinib has an FDA orphan drug designation for adjuvant treatment of metastatic thyroid cancer to re-induce RAI uptake EXCLUSION CRITERIA: -Patients with RAI-non avid disease documented by negative post-therapy whole body scans performed after previous RAI treatments and not subjected to re-differentiation therapy. * Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma, severe depression which might be exacerbated by thyroid hormone withdrawal. * Patients with spinal or brain metastases as they are at risk of TSH-stimulation induced swelling of metastatic lesions leading to potentially detrimental side effects. These patients will be evaluated per the standard of care protocol 77-DK-0096. * Pregnant or lactating women per self report. * Adults who are incapable of providing informed consent.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Differentiated thyroid cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Light-Based probe aims to spot thyroid cancer faster
- Mapping how thyroid tumors spread and what surgery leaves behind
- Antibody-Drug conjugate targets TROP-2 in Hard-to-Treat thyroid cancers
- Can a video keep thyroid cancer patients on track after surgery?
- Can doctors safely watch small thyroid cancers instead of removing them?
- Aortic graft used to rebuild windpipe in thyroid cancer surgery