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

December 15, 2022 updated by: Jena University Hospital

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thüringen
      • Jena, Thüringen, Germany, 07745
        • University Hospital Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with histological secured differentiated thyroid cancer stationary for treatment or diagnostic with radioiodine

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jena University Hospital

Investigators

  • Principal Investigator: Martin Freesmeyer, Dr. med., Study Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ACTUAL)

December 1, 2022

Study Completion (ACTUAL)

December 1, 2022

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 13, 2016

First Posted (ESTIMATE)

May 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-131-07/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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