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CompletedNCT02773667RETENTIONUpdated Dec 16, 2022

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

An observational study in Thyroid Carcinoma, sponsored by Jena University Hospital. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-16.

Sponsored by Jena University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
83
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 83 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Jena University Hospital is the lead sponsor of 62 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Eligibility 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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
83 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Correlation between estimated renal function and biological half life of 131-I

    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.

    Time frame: 2 years

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Study locations

1 site
  • University Hospital Jena
    Jena, Thüringen 07745, Germany
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02773667
Lead sponsor
Jena University Hospital
Responsible party
Sponsor
First posted
May 16, 2016
Start date
Jan 2016
Primary completion
Dec 2022
Completion
Dec 2022
Last update
Dec 16, 2022

Study contacts

Martin Freesmeyer, Dr. med.
principal investigator · Study Principal Investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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