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

Thyroid Carcinoma Clinical Trial

— RETENTION  

Official title:

Relationship Between Estimated Glomerular Filtration Rate and Biological Half-life of 131I. Prospective Analysis in Patients With Differentiated Thyroid Carcinoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773667
• Other study ID #: I-131-07/2015
• Status: Completed
• Start date: January 2016
• Est. completion date: December 2022

Study information

• Verified date: December 2022
• Source: Jena University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Thyroid Carcinoma
• Thyroid Diseases
• Thyroid Neoplasms

Locations

Country	Name	City	State
Germany	University Hospital Jena	Jena	Thüringen

Sponsors (1)

Lead Sponsor	Collaborator
Jena University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between estimated renal function and biological half life of 131-I	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.	2 years