Nodule Solitary ThyroidNCT04663451
An Assessment of the Occurrence of Hypothyroidism in Patients Treated With RAI for Hyperthyroidism.
An observational study of Nodule Solitary Thyroid and Toxic Multinodular Goiter, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Low RAIU in patients with hyperthyroidism represents a common obstacle in the treatment with RAI. Therefore, a higher dose of RAI must be administered to cure hyperthyroidism in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nodule Solitary Thyroid, Toxic Multinodular Goiter, Radioactive Iodine-Induced Hypothyroidism
- What is being tested?
- radioacive iodine therapy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Sep 2020to May 2021
- Phase
- Observational
- 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
Study population: Hyperthyroid patients, either subclinical or overt, who have undergone RAI treatment in the time period of 2005-2015. They have underlying toxic multinodular goiter or a toxic nodule.
Who may be able to join
- Hyperthyroid patients, either subclinical or overt, who have undergone RAI treatment in the period of 2005-2015.
Who cannot join
- Prior use of L-thyroxine
- Prior thyroid surgery
- Prior RAI treatment
- Patients with thyroiditis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Assessment of the Occurrence of Hypothyroidism in Patients Treated With RAI For Hyperthyroidism, And it's Prognostic Factors.
Low RAIU in patients with hyperthyroidism represents a common obstacle in the treatment with RAI. Therefore, a higher dose of RAI must be administered to cure hyperthyroidism in these patients. If we treat patients with thiamazole before starting RAI treatment, serum TSH will rise and result in an increase in iodine uptake by the thyroid gland. By doing so, the dose of RAI to be administered might be lowered to achieve similar therapeutic efficacy.
In the past, either calculated or fixed doses of 131I have been used to treat hyperthyroidism. The supposed advantage of a calculated dose compared to a fixed dose is the lowering of hypothyroidism frequency. However, various research papers have contradicted this statement.
Read more
Antithyroid drugs and RAI therapy have been widely used in the past, either in combination, or independent from one another. This has been done primarily in older patients, to reduce the risk of exacerbation of hyperthyroid symptoms after initiation of RAI.
The use of propylthiouracil has been shown to decrease the response rate after RAI due to radioprotective effects.
The use of methimazole and carbimazole did not have a negative effect on treatment failure, as long as the medication was discontinued various days before RAI administration. Although this statement is contested in other studies.
It is interesting to evaluate retrospective data of patients treated with RAI to evaluate prognostic factors of treatment respons and post RAI hypothyroidism.
- Conditions
- Nodule Solitary Thyroid, Toxic Multinodular Goiter, Radioactive Iodine-Induced Hypothyroidism
- Being tested
- radioacive iodine therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radioacive iodine therapyRadiation
Hyperthyroid patients who have undergone radioactive iodine treatment to cure them from their hyperthyroidism.
| Study group | Role | What they receive |
|---|---|---|
| Toxic Nodule | Hyperthyroid patients with underlying toxic nodule Receives: Radiation: radioacive iodine therapy | |
| Toxic multinodular goiter | Hyperthyroid patients with underlying toxic multinodular goiter Receives: Radiation: radioacive iodine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients in which hypothyroidism occurs
The proportion of patients in which hypothyroidism occurs after radioiodine treatment
Measured: Within 1 year after treatment
The proportion of patients in which hypothyroidism occurs
The proportion of patients in which hypothyroidism occurs after radioiodine treatment
Measured: Between 1-2 years after treatment
The proportion of patients in which hypothyroidism occurs
The proportion of patients in which hypothyroidism occurs after radioiodine treatment
Measured: Between 2-5 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start11 Sep 2020
- Primary completion24 Nov 2020
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nodule Solitary ThyroidStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brigitte Velkeniers, Universitair Ziekenhuis Brussel
- Investigators
- Corina Andreescu, Doctorate, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663451
- Sponsor's protocol ID
- 2019/435
- Status last verified
- Apr 2021
- First submitted
- 26 Nov 2020
- Last updated
- 19 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data may be shared with other researchers to continue this type of research in this particular domain and to answer further questions that arise from the process of this study.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Occurrence of Hypothyroidism in Patients Treated With RAI For Hyperthyroidism, And it's Prognostic Factors.
- ClinicalTrials.gov ID
- NCT04663451
- Acronym / sponsor ID
- 2019/435
- Conditions
- Nodule Solitary Thyroid, Toxic Multinodular Goiter, Radioactive Iodine-Induced Hypothyroidism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- May 2021 (estimated)
- First posted
- 11 Dec 2020 (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.
Low RAIU in patients with hyperthyroidism represents a common obstacle in the treatment with RAI. Therefore, a higher dose of RAI must be administered to cure hyperthyroidism in these patients. If we treat patients with thiamazole before starting RAI treatment, serum TSH will rise and result in an increase in iodine uptake by the thyroid gland. By doing so, the dose of RAI to be administered might be lowered to achieve similar therapeutic efficacy.
In the past, either calculated or fixed doses of 131I have been used to treat hyperthyroidism. The supposed advantage of a calculated dose compared to a fixed dose is the lowering of hypothyroidism frequency. However, various research papers have contradicted this statement.
Antithyroid drugs and RAI therapy have been widely used in the past, either in combination, or independent from one another. This has been done primarily in older patients, to reduce the risk of exacerbation of hyperthyroid symptoms after initiation of RAI.
The use of propylthiouracil has been shown to decrease the response rate after RAI due to radioprotective effects.
The use of methimazole and carbimazole did not have a negative effect on treatment failure, as long as the medication was discontinued various days before RAI administration. Although this statement is contested in other studies.
It is interesting to evaluate retrospective data of patients treated with RAI to evaluate prognostic factors of treatment respons and post RAI hypothyroidism.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toxic Nodule | – | Radiation: radioacive iodine therapyHyperthyroid patients with underlying toxic nodule |
| Toxic multinodular goiter | – | Radiation: radioacive iodine therapyHyperthyroid patients with underlying toxic multinodular goiter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hyperthyroid patients, either subclinical or overt, who have undergone RAI treatment in the time period of 2005-2015. They have underlying toxic multinodular goiter or a toxic nodule.
Key inclusion criteria (1 listed)
- Hyperthyroid patients, either subclinical or overt, who have undergone RAI treatment in the period of 2005-2015.
Key exclusion criteria (4 listed)
- Prior use of L-thyroxine
- Prior thyroid surgery
- Prior RAI treatment
- Patients with thyroiditis
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 |
|---|---|---|
| radioacive iodine therapyHyperthyroid patients who have undergone radioactive iodine treatment to cure them from their hyperthyroidism. | Radiation | Toxic Nodule, Toxic multinodular goiter |
Primary outcome
The proportion of patients in which hypothyroidism occurs
Time frame: Within 1 year after treatment
The proportion of patients in which hypothyroidism occurs after radioiodine treatment
The proportion of patients in which hypothyroidism occurs
Time frame: Between 1-2 years after treatment
The proportion of patients in which hypothyroidism occurs after radioiodine treatment
The proportion of patients in which hypothyroidism occurs
Time frame: Between 2-5 years after treatment
The proportion of patients in which hypothyroidism occurs after radioiodine treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: Undecided. The data may be shared with other researchers to continue this type of research in this particular domain and to answer further questions that arise from the process of this study.
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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.
Corina Andreescu, Doctorate principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nodule Solitary Thyroid and Toxic Multinodular Goiter, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 4 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 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The proportion of patients in which hypothyroidism occurs (time frame: Within 1 year after treatment). The study lists 3 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 19 Apr 2021.