Graves DiseaseNCT06537141
Role of Embolization of Thyroid Arteries as a Treatment for Different Thyroid Disorders
A study testing selective embolization of thyroid arteries (SETA) in people with Graves Disease and Goiter, Nodular, run by Assiut University.
Trial summary
To investigate the safety and efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Disease, Goiter, Nodular, Goiter Malignant
- What is being tested?
- selective embolization of thyroid arteries (SETA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- A- diffuse and Nodular goiter:
- B-Toxic goiter:
- C-Thyroid cancer:
Who cannot join
- Significant bleeding diathesis. B. Contraindication for contrast media (renal impairment or allergy). C. Severe atherosclerotic disease prevent arterial catheterization. D. Refusal of signing a consent
About this study
Official title: Role of Selective Embolization of Thyroid Arteries (SETA) as an Adjunctive or Definitive Treatment for Different Thyroid Disorders
To investigate the safety and efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders
Read the detailed description
In graves disease Traditional forms of treatment of the thyroid diseases: pharmacotherapy, radioiodine therapy and surgery can not always be applied. Intolerance, side effects of antithyroid drugs, low iodine uptake, high risk of surgery or disagreement with the proposed treatment was the reason for seeking alternative treatment methods.
Also in cases of large sized thyroid nodule and retrosternal extension, surgery may carries out a lot of comorbidities .
With the development of interventional radiology, and gained experience in the use of arterial embolization, this method has become possible to use in treatment of thyroid diseases. The essence of this treatment is to shut down blood flow in major arteries of the thyroid by direct injection of embolizing materials (PVA) into the vessel's.
. The consequence of acute ischemia is necrosis of the glandular tissue in a field being supplied by this artery. Further repair processes and fibrosis lead to a reduction of active thyroid hormone synthesis and restriction of thyroid gland. Effects of embolization on angiogenesis, apoptosis and autoimmune reactions contribute to compensation thyroid function and significant reduction a goiter volume in course of Graves' disease. Preoperative selective embolization of a huge goiter or thyroid cancer improves surgery outcomes, reduces the risk of hemorrhage and damage to surrounding tissue. Palliative use of embolization in advanced stages of thyroid cancer reduces symptoms and improves quality of life. Little invasive nature of this procedure, the lack of serious undesirable coincidence makes embolization of thyroid arteries an attractive form of a therapy, which may become a therapeutic option in many difficult clinical situations and improve the clinical effectiveness of treatment of thyroid disease
- Conditions
- Graves Disease, Goiter, Nodular, Goiter Malignant, Goiter Diffuse
- Being tested
- selective embolization of thyroid arteries (SETA)
- Keywords
- Embolization of thyroid arteries
- Medical subject headings
- Graves Disease, Goiter, Nodular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective embolization of thyroid arteries (SETA)Procedure or surgery
selective embolization of thyroid arteries
| Study group | Role | What they receive |
|---|---|---|
| graves disease patients | Active comparator | Not described Receives: Procedure: selective embolization of thyroid arteries (SETA) |
| multinodular goiter | Active comparator | Not described Receives: Procedure: selective embolization of thyroid arteries (SETA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the safety of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders
Safety measured according to incidence of major and minor complications compared to thyroidectomy.
Measured: Up to 12 months follow up after embolization
To investigate the efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders
in hyperfunctiong (toxic) disorders Efficacy measured according to thyroid profile levels in certain time interval post procedure, every 3 months time interval and rate of hyper functioning recurrence in comparison to thyroidectomy.
In diffuse or nodular goiter we measure efficacy by percentage of size reduction post procedure in comparison to primary size just before procedure
Measured: Up to 12 months follow up after embolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start10 Aug 2024 (estimated)
- Primary completion9 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdelRahman Ahmad abdAllah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537141
- Sponsor's protocol ID
- 3ekremaH
- Status last verified
- Aug 2024
- First submitted
- 12 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Selective Embolization of Thyroid Arteries (SETA) as an Adjunctive or Definitive Treatment for Different Thyroid Disorders
- ClinicalTrials.gov ID
- NCT06537141
- Acronym / sponsor ID
- 3ekremaH
- Conditions
- Graves Disease, Goiter, Nodular, Goiter Malignant, Goiter Diffuse
- Keywords
- Embolization of thyroid arteries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 9 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 5 Aug 2024 (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.
To investigate the safety and efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders
Detailed description
In graves disease Traditional forms of treatment of the thyroid diseases: pharmacotherapy, radioiodine therapy and surgery can not always be applied. Intolerance, side effects of antithyroid drugs, low iodine uptake, high risk of surgery or disagreement with the proposed treatment was the reason for seeking alternative treatment methods.
Also in cases of large sized thyroid nodule and retrosternal extension, surgery may carries out a lot of comorbidities .
With the development of interventional radiology, and gained experience in the use of arterial embolization, this method has become possible to use in treatment of thyroid diseases. The essence of this treatment is to shut down blood flow in major arteries of the thyroid by direct injection of embolizing materials (PVA) into the vessel's.
. The consequence of acute ischemia is necrosis of the glandular tissue in a field being supplied by this artery. Further repair processes and fibrosis lead to a reduction of active thyroid hormone synthesis and restriction of thyroid gland. Effects of embolization on angiogenesis, apoptosis and autoimmune reactions contribute to compensation thyroid function and significant reduction a goiter volume in course of Graves' disease. Preoperative selective embolization of a huge goiter or thyroid cancer improves surgery outcomes, reduces the risk of hemorrhage and damage to surrounding tissue. Palliative use of embolization in advanced stages of thyroid cancer reduces symptoms and improves quality of life. Little invasive nature of this procedure, the lack of serious undesirable coincidence makes embolization of thyroid arteries an attractive form of a therapy, which may become a therapeutic option in many difficult clinical situations and improve the clinical effectiveness of treatment of thyroid disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| graves disease patients | Active comparator | Procedure: selective embolization of thyroid arteries (SETA) |
| multinodular goiter | Active comparator | Procedure: selective embolization of thyroid arteries (SETA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (1 listed)
- Significant bleeding diathesis. B. Contraindication for contrast media (renal impairment or allergy). C. Severe atherosclerotic disease prevent arterial catheterization. D. Refusal of signing a consent
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 |
|---|---|---|
| selective embolization of thyroid arteries (SETA)selective embolization of thyroid arteries | Procedure or surgery | graves disease patients, multinodular goiter |
Primary outcome
To investigate the safety of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders
Time frame: Up to 12 months follow up after embolization
Safety measured according to incidence of major and minor complications compared to thyroidectomy.
To investigate the efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders
Time frame: Up to 12 months follow up after embolization
in hyperfunctiong (toxic) disorders Efficacy measured according to thyroid profile levels in certain time interval post procedure, every 3 months time interval and rate of hyper functioning recurrence in comparison to thyroidectomy. In diffuse or nodular goiter we measure efficacy by percentage of size reduction post procedure in comparison to primary size just before procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing selective embolization of thyroid arteries (SETA) in people with Graves Disease and Goiter, Nodular, 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the safety of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders (time frame: Up to 12 months follow up after embolization). The study lists 2 primary outcomes in all. 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 Aug 2024.