Iodine Uptake After a Low Iodine Diet (IULID)
The Uptake of Radioactive Iodine Before and After a Low Iodine Diet in Patients With Differentiated Thyroid Carcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rationale:
Differentiated thyroid carcinoma (DTC) is the most common form of thyroid cancer. The initial treatment of DTC consists of a total thyroidectomy followed by ablation therapy with radioactive iodine (131I) which destroy residual thyroid (cancer) tissue. Before starting the (ablation) therapy with 131I, patients have to follow a low iodine diet (LID) reducing the iodine intake < 50 mcg per day. Depleting the overall iodine store in the body theoretically maximizes the expression of the sodium-iodine symporter (NIS). This increased NIS expression results in an increase of the uptake of 131I in remaining thyroid (cancer) cells during 131I therapy and therefore improves the ablation success rates. However, there is no prospective data to support this, merely some retrospective contradictionary data. Patients experience the strict adherence to LID as stressful, distasteful and overwhelming in combination with a new diagnosis of cancer and withdrawal from thyroid hormone. Besides, they are afraid to apply the LID inadequately, which complicates achieving a balanced diet, essential in cancer recovery.
Objective:
To compare the difference in thyroid uptake of a low dose radioactive iodine (10 MBq 123I or 37 MBq 123I), in DTC patients after thyroidectomy, before and after a LID of 7 days.
Study design: observational, single center study performed in the University Medical Center Groningen (UMCG) Groningen, the Netherlands.
Study population: Patients, men and women above the age of 18 years, with a histopathological confirmed diagnosis of DTC who will receive 131I ablation therapy and have to follow a LID according to the Dutch DTC guideline.
Main study parameters/endpoints: The primary endpoint is the clinical relevant difference of a twofold uptake increase, in the thyroid remnant after thyroidectomy in DTC patients, a 10 MBq 123I or 37 MBq 123I tracer dose before and after a LID of 7 days.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
- Burden: Low risk patients (according to the Dutch DTC guideline) will receive 10 MBq 123I twice, followed by a thyroid uptake measurement and will have to collect their urine for 24 hours twice. High risk patients (according to the Dutch DTC guideline) will receive 10 MBq 123I once, followed by a thyroid uptake measurement and have to collect their urine for 24 hours twice. On the day of the first administration of 10 MBq 123I, 1 blood sample (5 ml) will be collected. Low risk patients have to make three additional site visits to the UMCG, high risk patients two additional site visits.
- Risks: The administration of two times 10 MBq will lead to an extra radiation exposure of 0,76 mSv for low risk patients and 0,38 mSv for high risk patients. Blood sampling carriers a negligible risk of a hematoma. The 24 hours urine collection is without additional risk for the patient or the lab technician.
The note of the daily food intake is without additional risk for the patient.
- Benefits: None, participants will participate based on altruistic motives.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wouter Zandee, Dr.
- Phone Number: +31503613731
- Email: w.t.zandee@umcg.nl
Study Contact Backup
- Name: Mirthe Links, BSc.
- Phone Number: +31503610973
- Email: m.h.links@umcg.nl
Study Locations
-
-
Provincie Groningen
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Groningen, Provincie Groningen, Netherlands, 9713GZ
- Recruiting
- UMCG
-
Contact:
- Wouter T Zandee, MD PhD
- Phone Number: 050 361 6161
- Email: w.t.zandee@umcg.nl
-
Contact:
- Mirthe H Links, Bsc
- Phone Number: 050 361 6161
- Email: m.h.links@umcg.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Low iodine diet
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Iodine uptake
Time Frame: 7 days
|
Difference in iodine uptake in percentage
|
7 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wouter Zandee, Dr., University Medical Center Groningen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL65923.042.18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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