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Measurement of Iodolipids in the Thyroid Gland and Other Biological Samples (IODOLIP)

Primary Purpose

Thyroid

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Potassium iodide
Sponsored by
Prof. Gerasimos Sykiotis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thyroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    intervention group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2022
    Last Updated
    November 24, 2022
    Sponsor
    Prof. Gerasimos Sykiotis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05628506
    Brief Title
    Measurement of Iodolipids in the Thyroid Gland and Other Biological Samples
    Acronym
    IODOLIP
    Official Title
    Measurement of Iodolipids in the Thyroid Gland and Other Biological Samples
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    February 11, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Prof. Gerasimos Sykiotis

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Potassium iodide
    Intervention Description
    Patients will receive a single oral administration of a pharmacological dose (97.5 mg) of potassium iodide 20±4 hours before surgery.
    Primary Outcome Measure Information:
    Title
    Mean 2-iodoxehadecanal and delta-iodolactone in the thyroid sample
    Time Frame
    20±4 hours after administration of potassium iodide

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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. 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Prof. Gerasimos Sykiotis, MD, PhD
    Phone
    +41 (0)79 556 14 94
    Email
    Gerasimos.Sykiotis@chuv.ch

    12. IPD Sharing Statement

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    Measurement of Iodolipids in the Thyroid Gland and Other Biological Samples

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