ThyroidIODOLIPNCT05628506
Measurement of Iodolipids in the Thyroid Gland and Other Biological Samples
A study testing Potassium iodide in people with Thyroid, run by Prof. Gerasimos Sykiotis.
Trial summary
The research project is an open, parallel-group, single centre, randomized controlled trial that aims to assess the feasibility of measuring iodolipids in thyroid samples of patients during routine thyroid surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid
- What is being tested?
- Potassium iodide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 11 Feb 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
- Patients fulfilling all of the following inclusion criteria are eligible for the study:
- Patients with the capacity for discernment and who agree to participate in the study and sign the consent.
- Age ≥18 years.
- Indication for thyroid surgery due to either nontoxic single thyroid nodule (WHO disease classification 5A01.1) or nontoxic multinodular goitre (WHO disease classification 5A01.2).
- Normal thyroid function without anti-thyroid medication. This is ascertained by at least one serum TSH value within the reference range in the three months before surgery (if multiple values are available, the latest value should be normal). If no TSH values are available, a blood draw will be performed to measure TSH.
Who cannot join
- The presence of any one of the following exclusion criteria will lead to exclusion of the patient:
- Women who are pregnant or breastfeeding (a urine pregnancy test will be done at Visit 2 before randomization if applicable).
- Intention to become pregnant during the course of the study.
- Alcohol or drug abuse within the past 6 months.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the patient.
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
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- Use, within the last month before the scheduled surgery, of iodine-containing medications, i.e., iodine-containing anti-cough syrups or iodine-containing disinfectants. Non-iodine-containing anti-cough syrups and non-iodine-containing disinfectants are authorized.
- Use, within the last month before the scheduled surgery, of iodine-containing radiological contrast media. Non-iodine-containing radiological contrast media are authorized.
- Susceptibility to iodine-induced hyperthyroidism (i.e., toxic adenoma or toxic multinodular goiter, or previous episode of iodine-induced hyperthyroidism according to the medical history).
- Serum TSH (thyroid-stimulating hormone) level below the lower limit of the reference range.
- Graves' disease.
- Susceptibility to iodine-induced hypothyroidism (history of thyroid surgery, Hashimoto's thyroiditis, history of subacute or destructive thyroiditis).
- Titer of serum thyroid autoantibodies (anti-TSH receptor, anti-thyroperoxydase or antithyroglobulin) above the reference range.
- History of sialadenitis, regardless of etiology.
- History of allergic reactions (any grade) to radiological contrast media, iodine-containing disinfectants, anti-cough medications, or seafood; and known hypersensitivity to iodine.
- History of allergic reactions (any grade) to the excipients of the ""IODURE DE POTASSIUM 65 AApot cpr 65 mg" drug: lactosum anhydricum, cellulosum microcristallinum, magnesii stearas.
- Severe intolerance to lactose or galactose (patients having been recommended by their physician to adhere to a strict regime free of the offending agent).
- Concurrent treatment with lithium.
- Concurrent treatment with potassium-sparing diuretics.
- Nodule diagnosed as thyroid carcinoma or suspicious for thyroid carcinoma based on the results of a fine-needle aspiration biopsy or a tru-cut biopsy (if performed during the routine patient work-up as per standard indications).
- Patients with hyperkalemia.
- Dermatitis herpetiformis.
- Congenital myotonia.
- Hypocomplementemic urticaria/vasculitis.
- Chronic obstructive pulmonary disease
- Asthma
- Heart failure stage B, C or D
- Impaired renal function (eGFR <60 ml/min/1.73 m2)
- Normal urinary iodine concentration on the day of surgery (determined retrospectively).
Trial locations and contacts
No sites are listed yet.
About this study
The research project is an open, parallel-group, single centre, randomized controlled trial that aims to assess the feasibility of measuring iodolipids in thyroid samples of patients during routine thyroid surgery.
Read the detailed description
Twenty subjects will be included. Patients are randomized 1:1 to receive either a single oral administration of a pharmacological dose of potassium iodide 20±4 hours before surgery (10 patients), or nothing (10 patients):
- The dose administered will be 97.5 mg,
- Patients allocated to the control group will not receive any drug.
Two thyroid samples will be taken from the surgical specimen by a pathologist. Each sample will have a weight of approximatively 1 g, corresponding to a volume of approximately 1 cm3. We will select material containing tissue that corresponds to normal thyroid parenchyma (according to the preoperative ultrasound and direct inspection by the pathologist intraoperatively). The sample will be taken in the dedicated room next to the operating room by a pathologist who will confirm that the targeted area has no visible macroscopic lesion. In case of doubt, an alternative area free of lesion will be selected by the pathologist.
Patients are unblinded. The total maximum duration of the study for an individual patient is 42 days. The total duration of the clinical trial will be 3 years in order to include 20 patients.
- Conditions
- Thyroid
- Being tested
- Potassium iodide
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium iodideDrug
Patients will receive a single oral administration of a pharmacological dose (97.5 mg) of potassium iodide 20±4 hours before surgery.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Drug: Potassium iodide |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 2-iodoxehadecanal and delta-iodolactone in the thyroid sample
Measured: 20±4 hours after administration of potassium iodide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion11 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Gerasimos Sykiotis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Gerasimos Sykiotis, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628506
- Sponsor's protocol ID
- IODOLIP Study
- Acronym
- IODOLIP
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 28 Nov 2022
- 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 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Iodolipids in the Thyroid Gland and Other Biological Samples
- ClinicalTrials.gov ID
- NCT05628506
- Acronym / sponsor ID
- IODOLIP / IODOLIP Study
- Conditions
- Thyroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Prof. Gerasimos SykiotisUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 11 Feb 2026 (estimated)
- First posted
- 28 Nov 2022 (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 research project is an open, parallel-group, single centre, randomized controlled trial that aims to assess the feasibility of measuring iodolipids in thyroid samples of patients during routine thyroid surgery.
Detailed description
Twenty subjects will be included. Patients are randomized 1:1 to receive either a single oral administration of a pharmacological dose of potassium iodide 20±4 hours before surgery (10 patients), or nothing (10 patients):
- The dose administered will be 97.5 mg,
- Patients allocated to the control group will not receive any drug.
Two thyroid samples will be taken from the surgical specimen by a pathologist. Each sample will have a weight of approximatively 1 g, corresponding to a volume of approximately 1 cm3. We will select material containing tissue that corresponds to normal thyroid parenchyma (according to the preoperative ultrasound and direct inspection by the pathologist intraoperatively). The sample will be taken in the dedicated room next to the operating room by a pathologist who will confirm that the targeted area has no visible macroscopic lesion. In case of doubt, an alternative area free of lesion will be selected by the pathologist.
Patients are unblinded. The total maximum duration of the study for an individual patient is 42 days. The total duration of the clinical trial will be 3 years in order to include 20 patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Potassium iodide |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with the capacity for discernment and who agree to participate in the study and sign the consent.
- Age ≥18 years.
- Indication for thyroid surgery due to either nontoxic single thyroid nodule (WHO disease classification 5A01.1) or nontoxic multinodular goitre (WHO disease classification 5A01.2).
- Normal thyroid function without anti-thyroid medication. This is ascertained by at least one serum TSH value within the reference range in the three months before surgery (if multiple values are available, the latest value should be normal). If no TSH values are available, a blood draw will be performed to measure TSH.
Key exclusion criteria (29 listed)
- The presence of any one of the following exclusion criteria will lead to exclusion of the patient:
- Women who are pregnant or breastfeeding (a urine pregnancy test will be done at Visit 2 before randomization if applicable).
- Intention to become pregnant during the course of the study.
- Alcohol or drug abuse within the past 6 months.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the patient.
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 |
|---|---|---|
| Potassium iodidePatients will receive a single oral administration of a pharmacological dose (97.5 mg) of potassium iodide 20±4 hours before surgery. | Drug | intervention group |
Primary outcome
Mean 2-iodoxehadecanal and delta-iodolactone in the thyroid sample
Time frame: 20±4 hours after administration of potassium iodide
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Potassium iodide in people with Thyroid, run by Prof. Gerasimos Sykiotis.
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 5 inclusion and 29 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 28 Nov 2022. 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?
Contact Prof. Gerasimos Sykiotis, MD, PhD (+41 (0)79 556 14 94, Gerasimos.Sykiotis@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean 2-iodoxehadecanal and delta-iodolactone in the thyroid sample (time frame: 20±4 hours after administration of potassium iodide). 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 28 Nov 2022.