NCT05599139

Brief Summary

The goal of this clinical trial is to compare the difference in thyroid uptake of a low dose radioactive iodine (10 MBq 123-I or 37 MBq 123-I) in athyreotic patients with differentiated thyroid carcinoma before and after a low iodine diet (LID) of 7 days. The main question it aims to answer is: • What is the difference in iodine uptake before and after a LID of 7 days? Uptake of a low dose of 123-iodine will be measured in participants before and after a low iodine diet of 7 days. Researchers will compare the uptake (%) before and after the LID.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Feb 2023Aug 2026

First Submitted

Initial submission to the registry

October 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

February 22, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

October 25, 2022

Last Update Submit

February 5, 2026

Conditions

Keywords

Low iodine dietIodine uptake

Outcome Measures

Primary Outcomes (1)

  • Iodine uptake

    Difference in iodine uptake in percentage

    7 days

Study Arms (1)

Low iodine diet

OTHER

Patients recieve a low iodine diet. Consecutive iodine uptake measurements will be made before and after starting this low iodine diet. This study is constructed of only one study arm, and patients will be compared to themselves.

Behavioral: Low iodine diet

Interventions

Low iodine dietBEHAVIORAL

Before ablation and possible subsequent therapy with 131I, patients have to follow a low iodine diet (LID), reducing the iodine intake \< 50 mcg per day and thereby depleting the overall iodine store in the body.

Low iodine diet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients, men and women above the age of 18 years, have to be diagnosed with DTC and have to follow a LID prior to the 131I ablation therapy according to the Dutch DTC guideline
  • Patients have to be fit to adhere to the study protocol
  • Patients have to be able to read and understand the Dutch language

You may not qualify if:

  • Age \< 18 years
  • Patients using amiodarone
  • Patients receiving iodinated contrast \< 3 months before the LID
  • Pregnancy
  • Patients prepared for ablation therapy with rhTSH
  • Renal impairment, EGFR \<30ml/min/1,73m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMCG

Groningen, Provincie Groningen, 9713GZ, Netherlands

RECRUITING

Study Officials

  • Wouter Zandee, Dr.

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wouter Zandee, Dr.

CONTACT

Mirthe Links, BSc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 31, 2022

Study Start

February 22, 2023

Primary Completion

March 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

The IPD will not be available to other researchers as this is not included in the patient consent.

Locations