Empirical Radioactive Iodine Therapy in DTC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radioactive Iodine Therapy.
- Who it may be relevant to
- Registry conditions: Differentiated Thyroid Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Empirical Radioactive Iodine Therapy in Differentiated Thyroid Carcinoma Patients With Thyroglobulin Elevation Negative Iodine Scintigraphy (TENIS) Syndrome
Overview
The aim of the study is assessment the efficacy of empiric RAI therapy in DTC patients with elevated thyroglobulin levels and negative iodine scintigraphy.
Detailed description
Thyroid cancer is the most common endocrine malignancy. Differentiated thyroid cancer (DTC) accounting for more than 90% of all thyroid cancers.
The standard treatment of patients with (DTC) consists of surgery followed by radioactive iodine therapy (RAI).The response to initial therapy is usually assessed by serum thyroglobulin (Tg) levels and neck ultrasonography (US) according to American Thyroid Association (ATA) guidelines.
Some patients with elevated serum Tg levels don't not show evidence of structural disease during follow up.
Diagnostic iodine-131 (131I) whole body scan (WBS) has been largely used for assessment of disease status.
Empiric RAI administration can be considered in patients with elevated Tg values after the first treatment and without evidence of structural disease (negative iodine scintigraphy).
Our approach is assessment the efficacy of empiric RAI therapy in DTC patients with elevated thyroglobulin levels and negative iodine scintigraphy.
Interventions
- Drug Radioactive Iodine Therapy
empirical dose of RAI
Primary outcome measures
- efficacy of empirical radioactive iodine therapy [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- This study will include adult patients with pathologically proved DTC who underwent total thyroidectomy and received RAI therapy presented to our nuclear medicine unit with evidence of persistent or recurrent biochemical disease during follow up.
Exclusion criteria
- Undifferentiated thyroid cancer.
- Patients with evidence of structural disease.
- Patients less than 18 years old.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07453225 · ET of iodine in thyroid cancer