Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine

Completed

• Conditions: Thyroid Carcinoma

• Registration Number: NCT02773667
• Lead Sponsor: Jena University Hospital

Brief Summary

Correlation analysis between estimated renal function and biological half life of 131-I during radioiodine treatment of patients with differentiated thyroid cancer.

Detailed Description

131-I during radioiodine treatment of patients with differentiated thyroid cancer is mainly renally excreted. It is advised in the clinical guidelines that serum creatinine should be determined before applying 131-I and if necessary the administered dose should be reduced. Nevertheless no guideline gives advice in what extent the dose should be decreased. The adjustment is at the discretion of the attending physician.

Aim of this prospective study is to correlate the biological half life of 131-I with the renal function to give objective recommendations concerning the reduction of the applied dose in patients with limited renal function.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-16
• Status Verified: 2022-12
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• patients with differentiated thyroid carcinoma
• stationary for treatment or diagnostic with radioiodine
• state after thyroidectomy
• written consent of the patient
• minimum age 18 years

Exclusion Criteria

• no written consent of the patient
• patients with large residual thyroid tissue (iodine uptake > 10%)
• children under 18 years of age
• inclusion in concurrent interventional studies
• patients without TSH-stimulation by rhTSH

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between estimated renal function and biological half life of 131-I	2 years	The estimated renal function (estimated GFR) is measured via determination of serum creatinine and Cystatin C.; The biological half-life of I-131 is determined via whole-body dosimetry (whole-body probe and whole-body gamma camera) and blood probe measurement.; Update 2017/06/07: After analyzing the preliminary results (based on the first 48 patients) probe measurements are not longer needed in a simplified study design. Additionally, measuring the creatinine concentration is no longer needed in comparison to the Cystatin C measurements.

Trial Locations

Locations (1)

University Hospital Jena; 🇩🇪 Jena, Thüringen, Germany