Phase
Condition
Thyroid Cancer
Treatment
Thyroid hormone withdrawal
I-131
I-124
Clinical Study ID
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
INCLUSION CRITERIA:
Patients with established thyroid cancer diagnosis based on the pathology reportreviewed at the National Institutes of Health, who:
underwent total thyroidectomy plus or minus neck lymph node dissection asclinically indicated,
are presenting with known per structural imaging (US neck, CT or MRIneck/chest/abdomen/pelvis) persistent/recurrent disease either locally advancedor presenting with distant metastases; or
are presenting with suspected persistent/recurrent locoregional or distantmetastases based on the high risk features such as advanced tumor per pathologyreport (tumor size >4 cm, exrathyroidal extension, higher risk pathology suchas tall cell, columnar cell, poorly differentiated variant, follicular thyroidcancer with gross vascular invasion, positive margins after the surgery, bulkylymphadenopathy in the central and/or lateral neck), detectable/increasingbaseline/suppressed thyroglobulin (Tg) level or detectable/increasing anti-Tgantibody titers if anti-Tg antibodies are present.
are either RAI -naive or requiring repeated RAI therapy for locally advanceddisease or distant metastases or underwent therapy with BRAF inhibitor (dabrafenib or vemurafenib*) or selumetinib** for at least 4 weeks that mayre-induce RAI uptake.
Underwent imaging with either a CT or MRI of the brain and spine withgadolinium 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/24hour.
BRAF inhibitors are recommended by 2021 NCCN guidelines as one of themanagement options for BRAF mutant tumors(13,14)
Selumetinib has an FDA orphan drug designation for adjuvanttreatment of metastatic thyroid cancer to re-induce RAI uptake
Exclusion
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 therapysuch as renal failure, congestive cardiac failure or active coexisting non-thyroidcarcinoma, severe depression which might be exacerbated by thyroid hormonewithdrawal.
Patients with spinal or brain metastases as they are at risk of TSH-stimulationinduced swelling of metastatic lesions leading to potentially detrimental sideeffects. 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.
Study Design
Study Description
Connect with a study center
National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.