NCT02773667

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

6.9 years

First QC Date

May 11, 2016

Last Update Submit

December 15, 2022

Conditions

Outcome Measures

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.

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with histological secured differentiated thyroid cancer stationary for treatment or diagnostic with radioiodine

You may qualify if:

  • patients with differentiated thyroid carcinoma
  • stationary for treatment or diagnostic with radioiodine
  • state after thyroidectomy
  • written consent of the patient
  • minimum age 18 years

You may not qualify if:

  • no written consent of the patient
  • patients with large residual thyroid tissue (iodine uptake \> 10%)
  • children under 18 years of age
  • patients without TSH-stimulation by rhTSH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Jena

Jena, Thuringia, 07745, Germany

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Martin Freesmeyer, Dr. med.

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 16, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 16, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations