Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Completed
NCT Number: NCT01945125
Effects of THW and rhTSH in Glomerular Filtration Rate During RIT
To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during radioiodine therapy in renal function.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Radioiodine therapy in thyroid carcinoma is a procedure performed for over six decades, and there is a vast literature in respect of its value in the complementary treatment of this neoplasia. This procedure also promotes a reliable follow-up based on sequential thyroglobulin dosages and makes possible to reduce the disease recurrence rate. One of the main aspects of the patients preparation before receiving the radioiodine consists in promoting stimulation for an effective uptake of the radioiodine, obtained either by endogenously TSH level elevation after post-surgical thyroid hormone withdrawal, or exogenously after use of recombinant human TSH. This last alternative does not demand suspension of thyroid hormone reposition after total thyroidectomy. Although not fully comprehended, it is known that hypothyroidism results in renal function hazard, which is reverted after hormonal reposition. It is also known that renal function modifies the radioiodine residence time and that the longer this time, the greater the patient's radiation exposure will be, and consequently with undesired irradiation of healthy tissues and organs. So theoretically stimulating the patient with recombinant human TSH could avoid the transient deficient renal function, promoting a lower radioiodine residence time and consequently lowering radiation exposure in this therapy.
This project aims to evaluate the effects of the different stimulation, endogenous and exogenous, over renal function by glomerular filtration rate determined by 51Cr-EDTA. This will be a controlled and randomized study in which 44 patients that has clinical indication of remnant ablative radioiodine treatment will be prepared by either one of the TSH stimulation procedures. Additionally radiation dosimetry calculus will be done to analyze the levels of the patient's radiation exposure associated with each of the uptake stimulation procedures for radioiodine therapy.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Normal Renal Function
Exclusion criteria
- Abnormal Renal Function
- Renal metastasis
Treatment and study plan
rhTSH Group
OtherPatients receiving rhTSH for RIT stimulation
Primary outcomes
-
Observation of differences in glomerular filtration rate with THW or rhTSH in radioiodine therapy
Time frame: participants will be followed during radioiodine treatment, from the decision of treatment to the post treatment whole body scan, an expected average of 2 months follow up
Sponsors and collaborators
Lead sponsor
University of Sao Paulo General Hospital
Other
Registry information
Official study title
Effects of Thyroid Hormone Withdrawal and Recombinant Human Thyroid Stimulating Hormone in Glomerular Filtration Rate During Radioiodine Therapy
Important dates
- Study start
- 2011
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Sep 18, 2013
- Registry last updated
- Dec 10, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.