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Study of 124-I-PET/CT Dosimetry in Differentiated Thyroid Cancer

This study is for people with differentiated thyroid cancer that has returned or spread after initial treatment. It aims to compare how radioactive iodine (I-124) is absorbed in your body and tumors when you're prepared in two different ways: with Thyrogen (a drug that stimulates your thyroid) or by withdrawing thyroid hormone. You would receive I-124 and I-131 (a treatment for thyroid cancer). Researchers want to see if the I-124 scans can accurately predict how well the I-131 treatment will work. This study is enrolling about 30 participants aged 18 to 90 years old.

Study design
This is an interventional study with a planned enrollment of 30 participants. It compares two methods of preparing patients for radioactive iodine imaging and treatment.
What's involved
You would receive Thyrogen injections, I-124 capsules, and I-131 treatment. Thyroid hormone withdrawal would also be part of the process during weeks 4 through 8.
Compensation
Not stated in the trial record.
Follow-up
Researchers will evaluate your response to treatment at 1, 2, 3, 4, and 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03841617

The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer

Recruiting
PHASE2Ages 18–90InterventionalTreatment
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~30 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:ThyrogenI-131I-124Thyroid hormone withdrawal

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of the whole body and lesional 124I uptake within each patient prepared for imaging with human recombinant TSH (rhTSH) and thyroid hormone withdrawal (THW)
Measured over 9 weeks

Conditions

Thyroid Cancer

Explore related trials

Differentiated Thyroid Gland Carcinoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Joanna Klubo-Gwiezdzinska, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who to contact

Padmasree Veeraraghavan, R.N.
[email protected]
(301) 451-7710
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Comparison of the whole body and lesional 124I uptake within each patient prepared for imaging with human recombinant TSH (rhTSH) and thyroid hormone withdrawal (THW)9 weeks

    Whole body and lesional uptake of 124I calculated after preparation with human recombinant TSH (rhTSH) compared to dosimetry calculated after preparation using thyroid hormone withdrawal (THW)