An Assessment of the Occurrence of Hypothyroidism in Patients Treated With RAI for Hyperthyroidism.

NCT04663451 | Unknown

• 1 other identifier: 2019/435
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nodule Solitary Thyroid; Toxic Multinodular Goiter; Radioactive Iodine-Induced Hypothyroidism

Outcome Measures

Primary Outcomes (3)

• The proportion of patients in which hypothyroidism occurs

  The proportion of patients in which hypothyroidism occurs after radioiodine treatment

  Within 1 year after treatment

• The proportion of patients in which hypothyroidism occurs

  The proportion of patients in which hypothyroidism occurs after radioiodine treatment

  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

  Between 2-5 years after treatment

Study Arms (2)

Toxic Nodule

Hyperthyroid patients with underlying toxic nodule

Radiation: radioacive iodine therapy

Toxic multinodular goiter

Hyperthyroid patients with underlying toxic multinodular goiter

Radiation: radioacive iodine therapy

Interventions

radioacive iodine therapy RADIATION

Hyperthyroid patients who have undergone radioactive iodine treatment to cure them from their hyperthyroidism.

Toxic Nodule; Toxic multinodular goiter

Eligibility Criteria

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

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.

You may qualify if:

• Hyperthyroid patients, either subclinical or overt, who have undergone RAI treatment in the period of 2005-2015.

You may not qualify if:

• Prior use of L-thyroxine
• Prior thyroid surgery
• Prior RAI treatment
• Patients with thyroiditis

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Study Officials

• Corina Andreescu, Doctorate

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department of Internal Medicine and Endocrinology

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 11, 2020
• Study Start: September 11, 2020
• Primary Completion: November 24, 2020
• Study Completion: May 1, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

BE (1)