Skip to main content
OpenTrials
Completed

NCT Number: NCT02773667

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thyroid Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Jena

Jena, Thuringia, 07745, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation between estimated renal function and biological half life of 131-I

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Registry information

Official study title

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

Acronym: RETENTION

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
May 16, 2016
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.