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Effects of THW and rhTSH in Glomerular Filtration Rate During RIT

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ClinicalTrials.gov Identifier: NCT01945125
Recruitment Status : Completed
First Posted : September 18, 2013
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Description
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Brief Summary:
To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during radioiodine therapy in renal function.

Condition or disease Intervention/treatment Phase
Other Impaired Renal Function Disorder Other: rhTSH Group Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effects of Thyroid Hormone Withdrawal and Recombinant Human Thyroid Stimulating Hormone in Glomerular Filtration Rate During Radioiodine Therapy
Study Start Date : October 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : April 2014
Arms and Interventions
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Arm Intervention/treatment
No Intervention: THW Group
Patients under THW stimulation for RIT
rhTSH Group
Patients under rhTSH stimulation for RIT
 Other: rhTSH Group
Patients receiving rhTSH for RIT stimulation


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal Renal Function

Exclusion Criteria:

  • Abnormal Renal Function
  • Renal metastasis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945125


Locations
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Brazil
Instituto do Cancer do Estado de Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: George B Coura Filho, MD ICESP-FMUSP
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01945125    
Other Study ID Numbers: NP97/10
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: November 2013
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases