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NCT Number: NCT07453225

Empirical Radioactive Iodine Therapy in DTC

The aim of the study is assessment the efficacy of empiric RAI therapy in DTC patients with elevated thyroglobulin levels and negative iodine scintigraphy.

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Key information

Conditions

Differentiated Thyroid Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radioactive Iodine Therapy

Drug

empirical dose of RAI

Primary outcomes

  1. efficacy of empirical radioactive iodine therapy

    Time frame: 2 years

    by assessment of tumor marker (serum thyroglobulin ) if decreased after empirical therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Mona Nabil Helbawi

CONTACT

[email protected]

01097040135

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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