Actively Recruiting
The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
848 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study rationale High risk patients with differentiated thyroid cancer (DTC) require therapy with 131 I under thyroid stimulating hormone (TSH) stimulation. There are two methods of TSH stimulation endogenous by thyroid hormone withdrawal (THW) leading to hypothyroidism and exogenous by injection of human recombinant TSH (rhTSH Thyrogen). The appropriate 131-I activity utilized for treatment is either based on empiric fixed dosage choice or individually determined activity based on 131 I dosimetric calculations. Although dosimetry utilizing radioactive iodine isotope 131 I enables calculation of maximum safe dose, it does not estimate the tumoricidal activity necessary to destroy the metastatic lesions. The alternative radioactive isotope of iodine -124 I, used for positron emission tomography (PET) imaging, might be used for calculation not only the maximum safe131 I dose, but also to predict the absorbed dose in the metastatic lesions. Study objectives The primary objective of this study is to compare the 124 I -PET/CT lesional and whole body dosimetry in each individual patient with metastatic radioiodine (RAI)-avid thyroid cancer under preparation with rhTSH and THW. The secondary objective is to evaluate the predicted by PET/CT lesional uptake with the early response to therapy. Study design This is a phase 2 pilot prospective cohort study comparing the lesional and whole body dosimetry within each patient undergoing exogenous (rhTSH) and endogenous (THW) TSH stimulation and followed for 5 years. Interventions Each study participant will undergo rhTSH and THW-aided 124 I-PET/CT dosimetric evaluations and will be subsequently treated with THW-aided RAI activity based on dosimetric calculations enabling maximum safe dosage. The patients will be followed in 12+/-3 months intervals for 5 years. Sample size and population This pilot study will include 30 patients with high risk differentiated thyroid cancer presenting with distant and/or loco-regional metastases.
CONDITIONS
Official Title
The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with thyroid cancer confirmed by pathology report reviewed at the National Institutes of Health
- Patients who have undergone total thyroidectomy with or without neck lymph node dissection as needed
- Patients with known persistent or recurrent disease confirmed by imaging showing local advanced or distant metastases
- Patients with suspected persistent or recurrent metastases based on high-risk tumor features or increasing thyroglobulin or anti-thyroglobulin antibody levels
- Patients who are either radioactive iodine (RAI) naive or require repeated RAI therapy for advanced disease or distant metastases
- Patients treated with BRAF inhibitors or selumetinib for at least 4 weeks to re-induce RAI uptake
- Patients who have had brain and spine imaging with gadolinium contrast to check for metastases
- Age 18 years or older
- 24-hour urine iodine excretion less than or equal to 150 micrograms per 24 hours
You will not qualify if you...
- Patients with RAI-non avid disease shown by negative scans after previous RAI treatments without re-differentiation therapy
- Patients with serious medical conditions limiting testing or therapy, such as renal failure, congestive heart failure, active non-thyroid cancer, or severe depression worsened by thyroid hormone withdrawal
- Patients with spinal or brain metastases at risk of harmful TSH-stimulation side effects
- Pregnant or breastfeeding women
- Adults unable to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
P
Padmasree Veeraraghavan, R.N.
CONTACT
J
Joanna Klubo-Gwiezdzinska, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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