Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine (RETENTION)
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ClinicalTrials.gov Identifier: NCT02773667 |
Recruitment Status :
Recruiting
First Posted : May 16, 2016
Last Update Posted : August 14, 2019
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Condition or disease |
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Thyroid Carcinoma |
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 |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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 9329805 | martin.freesmeyer@med.uni-jena.de | |
Contact: Anke Werner | +49 3641 9329805 | anke.werner@med.uni-jena.de |
Germany | |
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 |
Responsible Party: | Jena University Hospital |
ClinicalTrials.gov Identifier: | NCT02773667 |
Other Study ID Numbers: |
I-131-07/2015 |
First Posted: | May 16, 2016 Key Record Dates |
Last Update Posted: | August 14, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Carcinoma Thyroid Neoplasms Thyroid Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Head and Neck Neoplasms |