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JOURNAL ONKOLOGIE – STUDIE
RETENTION

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

Rekrutierend

NCT-Nummer:
NCT02773667

Studienbeginn:
Januar 2016

Letztes Update:
14.08.2019

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Thyroid Diseases, Thyroid Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Jena University Hospital

Collaborator:
-

Studienleiter

Martin Freesmeyer, Dr. med.
Principal Investigator
Study Principal Investigator

Kontakt

Martin Freesmeyer, Dr. med.
Kontakt:
Phone: +49 3641 9329805
E-Mail: martin.freesmeyer@med.uni-jena.de
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Jena
07745 Jena
(Thüringen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Martin Freesmeyer, Dr. med.
Phone: +49 3641 9329805

Anke Werner
Phone: +49 3641 9329805
E-Mail: Anke.Werner@med.uni-jena.de
» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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.

Quelle: ClinicalTrials.gov


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