Differentiated Thyroid CancerPhase 1/2NCT07453225
Empirical Radioactive Iodine Therapy in DTC
A Phase 1/2 study testing Radioactive Iodine Therapy in people with Differentiated Thyroid Cancer, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Cancer
- What is being tested?
- Radioactive Iodine Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Undifferentiated thyroid cancer.
- Patients with evidence of structural disease.
- Patients less than 18 years old.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Differentiated Thyroid Cancer
- Being tested
- Radioactive Iodine Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive Iodine TherapyDrug
empirical dose of RAI
| Study group | Role | What they receive |
|---|---|---|
| patients received empirical dose of RAI | Experimental | patients treated with empirical dose Receives: Drug: Radioactive Iodine Therapy |
| patients didn't receive empirical dose of RAI | No intervention | patients monitored without empirical RAI dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of empirical radioactive iodine therapy
by assessment of tumor marker (serum thyroglobulin ) if decreased after empirical therapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Nabil Helbawi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453225
- Sponsor's protocol ID
- ET of iodine in thyroid cancer
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Empirical Radioactive Iodine Therapy in Differentiated Thyroid Carcinoma Patients With Thyroglobulin Elevation Negative Iodine Scintigraphy (TENIS) Syndrome
- ClinicalTrials.gov ID
- NCT07453225
- Acronym / sponsor ID
- ET of iodine in thyroid cancer
- Conditions
- Differentiated Thyroid Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| patients received empirical dose of RAI | Experimental | Drug: Radioactive Iodine Therapypatients treated with empirical dose |
| patients didn't receive empirical dose of RAI | No intervention | –patients monitored without empirical RAI dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Undifferentiated thyroid cancer.
- Patients with evidence of structural disease.
- Patients less than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radioactive Iodine Therapyempirical dose of RAI | Drug | patients received empirical dose of RAI |
Primary outcome
efficacy of empirical radioactive iodine therapy
Time frame: 2 years
by assessment of tumor marker (serum thyroglobulin ) if decreased after empirical therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radioactive Iodine Therapy in people with Differentiated Thyroid Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Nabil Helbawi (01097040135, monahelbawi561@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of empirical radioactive iodine therapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.