Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine (RETENTION)
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|ClinicalTrials.gov Identifier: NCT02773667|
Recruitment Status : Unknown
Verified August 2019 by Jena University Hospital.
Recruitment status was: Recruiting
First Posted : May 16, 2016
Last Update Posted : August 14, 2019
|Condition or disease|
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|
|Estimated Enrollment :||110 participants|
|Official Title:||Relationship Between Estimated Glomerular Filtration Rate and Biological Half-life of 131I. Prospective Analysis in Patients With Differentiated Thyroid Carcinoma.|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773667
|Contact: Martin Freesmeyer, Dr. med.||+49 3641 email@example.com|
|Contact: Anke Werner||+49 3641 firstname.lastname@example.org|
|University Hospital Jena||Recruiting|
|Jena, Thüringen, Germany, 07745|
|Contact: Martin Freesmeyer, Dr. med. +49 3641 9329805|
|Contact: Anke Werner +49 3641 9329805 Anke.Werner@med.uni-jena.de|
|Principal Investigator:||Martin Freesmeyer, Dr. med.||Study Principal Investigator|