Empirical Radioactive Iodine Therapy in DTC

February 27, 2026 updated by: Mona Nabil Helbawi, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients received empirical dose of RAI
patients treated with empirical dose
Drug: Radioactive Iodine Therapy
empirical dose of RAI
No Intervention: patients didn't receive empirical dose of RAI
patients monitored without empirical RAI dose

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ET of iodine in thyroid cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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