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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03349294
Other study ID # 106132-F
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date December 31, 2019

Study information

Verified date November 2017
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Thyroid cancer patients who have undergone total thyroidectomy, postoperative iodine 131 treatment to ablation residual thyroid tissue, is the current clinical practice. The effective half-life of the iodine 131 in the human body and in vivo exposure dose can be assessed by the in vivo kinetic model published by ICRP, but this model is based on standard healthy people and can not be corrected for patients undergoing total thyroidectomy. In this study, the investigators will use the actual clinical data to revise the biokinetic model of iodine-131 in patients with total thyroidectomy.


Description:

Methods Patients:All patients undergoing thyroidectomy and are about to be treated with iodine 131 30mCi will be invited to join the study. Exclusion with gastrointestinal surgery. Preparation:The patient of this study, their medication and diet and other matters needing attention, are in accordance with the original to accept iodine -131 30mCi treatment of the standard treatment. Imaging Protocol:After oral administration of iodine 131, patients must undergo whole body scan, for 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 168 hours, respectively. Image collection will use GE Infinia Hawkeye 4 SPECT / CT with high energy general purpose collimator. The imaging parameters use the original I-131 whole body scan protocol. Expected results:Image data is further analyzed by MATLAB software to obtain iodine 131 in the body of individual organs of the biological half-life and path strength percentage. This analysis can revise the iodine -131 biokinetic model of patients with total thyroidectomy, providing more accurate calculations and subsequent studies.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date December 31, 2019
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - All patients undergoing thyroidectomy and are about to be treated with iodine 131 30mCi will be invited to join the study. Exclusion Criteria: - Exclusion with gastrointestinal surgery.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Far Eastern Memorial Hospital New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The I-131 distributed among the internal organs after the dose administration can be thoroughly analyzed according to a revised MATLAB program. Image data is further analyzed by MATLAB software After oral administration of iodine 131, patients must undergo whole body scan, for 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 168 hours, respectively.
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