Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00011463

Trial Description

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Title

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

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Trial Acronym

RETENTION

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00011463
  •   2017/05/08
  •   2016/05/11
  •   yes
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Secondary IDs

  •   NCT02773667  (ClinicalTrials.gov)
  •   I-131-07/2015  (Jena University Hospital)
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Health Condition or Problem studied

  •   Thyroid Carcinoma
  •   C73 -  Malignant neoplasm of thyroid gland
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- 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 and blood probe measurement.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2016/01/31
  •   110
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Jena University Hospital
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    • Study Principal Investigator
    • Martin Freesmeyer, Dr. med. 
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    • Martin Freesmeyer, Dr. med. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2016/12/12
* This entry means the parameter is not applicable or has not been set.