Measurement of Iodolipids in the Thyroid Gland and Other Biological Samples

NCT05628506 | Not Yet Recruiting

• 1 other identifier: IODOLIP Study
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Thyroid

Outcome Measures

Primary Outcomes (1)

• Mean 2-iodoxehadecanal and delta-iodolactone in the thyroid sample

  20±4 hours after administration of potassium iodide

Study Arms (2)

intervention group

EXPERIMENTAL

Drug: Potassium iodide

control group

NO INTERVENTION

Interventions

Potassium iodide DRUG

Patients will receive a single oral administration of a pharmacological dose (97.5 mg) of potassium iodide 20±4 hours before surgery.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Prof. Gerasimos Sykiotis: lead

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Potassium Iodide

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Iodides; Iodine Compounds; Inorganic Chemicals; Potassium Compounds

Central Study Contacts

Prof. Gerasimos Sykiotis, MD, PhD

CONTACT

+41 (0)79 556 14 94; Gerasimos.Sykiotis@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: February 11, 2026
• Last Updated: November 28, 2022

Record last verified: 2022-11