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

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04663451
Collaborator
(none)
150
1
7.6
19.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: radioacive iodine therapy

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
An Assessment of the Occurrence of Hypothyroidism in Patients Treated With RAI For Hyperthyroidism, And it's Prognostic Factors.
Actual Study Start Date :
Sep 11, 2020
Actual Primary Completion Date :
Nov 24, 2020
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Toxic Nodule

Hyperthyroid patients with underlying toxic nodule

Radiation: radioacive iodine therapy
Hyperthyroid patients who have undergone radioactive iodine treatment to cure them from their hyperthyroidism.

Toxic multinodular goiter

Hyperthyroid patients with underlying toxic multinodular goiter

Radiation: radioacive iodine therapy
Hyperthyroid patients who have undergone radioactive iodine treatment to cure them from their hyperthyroidism.

Outcome Measures

Primary Outcome Measures

  1. The proportion of patients in which hypothyroidism occurs [Within 1 year after treatment]

    The proportion of patients in which hypothyroidism occurs after radioiodine treatment

  2. The proportion of patients in which hypothyroidism occurs [Between 1-2 years after treatment]

    The proportion of patients in which hypothyroidism occurs after radioiodine treatment

  3. The proportion of patients in which hypothyroidism occurs [Between 2-5 years after treatment]

    The proportion of patients in which hypothyroidism occurs after radioiodine treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Hyperthyroid patients, either subclinical or overt, who have undergone RAI treatment in the period of 2005-2015.
Exclusion Criteria:
  • Prior use of L-thyroxine

  • Prior thyroid surgery

  • Prior RAI treatment

  • Patients with thyroiditis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitair Ziekenhuis Brussel Brussels Belgium 1090

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Corina Andreescu, Doctorate, Universitair Ziekenhuis Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Brigitte Velkeniers, Head of the department of Internal Medicine and Endocrinology, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT04663451
Other Study ID Numbers:
  • 2019/435
First Posted:
Dec 11, 2020
Last Update Posted:
Apr 19, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2021