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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02773667

Acronym

RETENTION

Enrollment

Registered

2016-05-16

Start date

2016-01-31

Completion date

2022-12-31

Last updated

2022-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Carcinoma

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results