Empirical Radioactive Iodine Therapy in DTC

Efficacy of Empirical Radioactive Iodine Therapy in Differentiated Thyroid Carcinoma Patients With Thyroglobulin Elevation Negative Iodine Scintigraphy (TENIS) Syndrome

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07453225

Enrollment

100

Registered

2026-03-05

Start date

2026-04-01

Completion date

2028-07-01

Last updated

2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Differentiated Thyroid Cancer

Brief summary

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

DRUGRadioactive Iodine Therapy

empirical dose of RAI

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Masking Description

Intervention model description

Model Description

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
efficacy of empirical radioactive iodine therapy	2 years	by assessment of tumor marker (serum thyroglobulin ) if decreased after empirical therapy

Contacts

CONTACTMona Nabil Helbawi

monahelbawi561@gmail.com01097040135

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026