Status:
RECRUITING
The Use of 124-I-PET/CT Whole Body and Lesional Dosimetry in Differentiated Thyroid Cancer
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Thyroid Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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 en...
Detailed Description
Study Description: Each study participant will undergo rhTSH and THW-aided 124IPET/ CT dosimetric evaluations and will be subsequently treated with THW-aided RAI activity based on dosimetric calculat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2035
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03841617
Start Date
July 29 2019
End Date
November 1 2035
Last Update
January 5 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892