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Effects of THW and rhTSH in Glomerular Filtration Rate During RIT

NCT ID: NCT01945125

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-04-30

Brief Summary

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To observe the influence of thyroid hormone withdrawal and of recombinant human TSH during radioiodine therapy in renal function.

Detailed Description

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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.

Conditions

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Other Impaired Renal Function Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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THW Group

Patients under THW stimulation for RIT

Group Type NO_INTERVENTION

No interventions assigned to this group

rhTSH Group

Patients under rhTSH stimulation for RIT

Group Type OTHER

rhTSH Group

Intervention Type OTHER

Patients receiving rhTSH for RIT stimulation

Interventions

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rhTSH Group

Patients receiving rhTSH for RIT stimulation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Normal Renal Function

Exclusion Criteria

* Abnormal Renal Function
* Renal metastasis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George B Coura Filho, MD

Role: PRINCIPAL_INVESTIGATOR

ICESP-FMUSP

Locations

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Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Coura-Filho GB, Willegaignon J, Buchpiguel CA, Sapienza MT. Effects of Thyroid Hormone Withdrawal and Recombinant Human Thyrotropin on Glomerular Filtration Rate During Radioiodine Therapy for Well-Differentiated Thyroid Cancer. Thyroid. 2015 Dec;25(12):1291-6. doi: 10.1089/thy.2015.0173. Epub 2015 Nov 5.

Reference Type DERIVED
PMID: 26446582 (View on PubMed)

Other Identifiers

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NP97/10

Identifier Type: -

Identifier Source: org_study_id