NCT05643365

Brief Summary

The purpose of this retrospective study was to clarify the possible risk factors of early hypothyroidism after RAI therapy in Graves' disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

9.8 years

First QC Date

November 25, 2022

Last Update Submit

October 10, 2023

Conditions

Radioactive Iodine-Induced Hypothyroidism in Graves Disease Patients

Outcome Measures

Primary Outcomes (1)

  • predictive factors of early hypothyroidism after RAI therapy

    Retrospective study from 2013 to 2022 to analyze the correlation between clinical, demographic\& and laboratory data and incidence of hypothyroidism by measuring thyroid function tests

    1 year

Secondary Outcomes (1)

  • the incidence of hypothyroidism within 1 year

    10 years

Study Arms (3)

Hypothyroidism

decreased hormone levels (FT3 \< 3.5 pmol/L, FT4 \< 11.5 pmol/L, TSH \> 4.78 μU/mL) and symptoms of hypothyroidism within 6 months' follow-up.

Radiation: Radioactive Iodine therapy

Euthyroidism

normal hormone levels (FT3 3.5 to 6.5 pmol/L, FT4 11.5 to 22.7 pmol/L, TSH 0.55 to 4.78 μU/mL), and no symptoms of hyperthyroidism after 6 months' follow-up

Radiation: Radioactive Iodine therapy

Hyperthyroidism

increased hormone levels (FT3 \> 6.5 pmol/L, FT4 \> 22.7 pmol/L, TSH \< 0.55 μU/mL) and symptoms of hyperthyroidism after 6 months' follow-up

Radiation: Radioactive Iodine therapy

Interventions

Radioactive Iodine therapyRADIATION

All the patient need to stop ATD and iodine-containing drugs for 5 days prior to RAI treatment, and followed a low-iodine diet for 2 weeks. After fasting and water deprivation for 8 h, all the patients took RAI orally in the morning. After taking RAI, the patients need to continue fasting and water deprivation for extra 2 h to avoid the effects of food on iodine absorption.

EuthyroidismHyperthyroidismHypothyroidism

Eligibility Criteria

Age13 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All thyrotoxic patients treated with RAI

You may qualify if:

  • Graves' disease patients after one year of RAI therapy .
  • Suppressed serum thyrotropin (TSH) \<0.55 µU/ml , elevated serum free triiodothyronine (FT3) \> 6.5 pmol/L , free thyroxin FT4 \>22.7 pmol/L .

You may not qualify if:

  • Patients with other causes of hyperthyroidism , such as toxic multinodular goiter and single toxic adenoma
  • Thyroid cancer
  • Recurrent GD
  • Previous Thyroid surgery
  • Patients can't complete the follow -up within 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuclear medicine unit, department of clinical oncology and nuclear medicine, Assiut university hospital

Asyut, Egypt

RECRUITING

Related Publications (3)

  • Smith TJ, Hegedus L. Graves' Disease. N Engl J Med. 2016 Oct 20;375(16):1552-1565. doi: 10.1056/NEJMra1510030. No abstract available.

    PMID: 27797318BACKGROUND

  • Hu RT, Liu DS, Li B. Predictive factors for early hypothyroidism following the radioactive iodine therapy in Graves' disease patients. BMC Endocr Disord. 2020 May 29;20(1):76. doi: 10.1186/s12902-020-00557-w.

    PMID: 32471411BACKGROUND

  • Demir BK, Karakilic E, Saygili ES, Araci N, Ozdemir S. Predictors of Hypothyroidism Following Empirical Dose Radioiodine in Toxic Thyroid Nodules: Real-Life Experience. Endocr Pract. 2022 Aug;28(8):749-753. doi: 10.1016/j.eprac.2022.05.001. Epub 2022 May 7.

    PMID: 35537668BACKGROUND

Study Officials

  • Hemat A Mahmoud, M.D

    Lecturer

    STUDY DIRECTOR

  • Hanan G Mostafa, M.D

    Professor

    STUDY CHAIR

Central Study Contacts

Aya A Alsanory, Master

CONTACT

00201063490867ayota17@gmail.com

Esraa R Hassan, M.D

CONTACT

00201098589000Esraaa.roshdy@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in nuclear medicine departement (South Egypt Cancer institute)

Study Record Dates

First Submitted

November 25, 2022

First Posted

December 8, 2022

Study Start

January 1, 2013

Primary Completion

November 1, 2022

Study Completion

December 1, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

EG(1)