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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
Sponsor:
Information provided by (Responsible Party):
Jena University Hospital

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

Condition or disease
Thyroid Carcinoma

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 Design
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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

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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.



Eligibility Criteria
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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
Study Population
Patients with histological secured differentiated thyroid cancer stationary for treatment or diagnostic with radioiodine
Criteria

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
Contacts and Locations
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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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
Jena University Hospital
Investigators
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Principal Investigator: Martin Freesmeyer, Dr. med. Study Principal Investigator
More Information
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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
Additional relevant MeSH terms:
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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