Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01945125 |
| Other study ID # |
NP97/10 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 9, 2013 |
| Last updated |
December 9, 2014 |
| Start date |
October 2011 |
| Est. completion date |
April 2014 |
Study information
| Verified date |
November 2013 |
| Source |
University of Sao Paulo General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Brazil: National Committee of Ethics in Research |
| Study type |
Interventional
|
Clinical Trial Summary
To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during
radioiodine therapy in renal function.
Description:
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.
