NCT03349294

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 23, 2022

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

October 20, 2017

Last Update Submit

February 22, 2022

Conditions

Thyroidectomy

Keywords

ThyroidThyroidectomyIodineBiokineticAblation

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • All patients undergoing thyroidectomy and are about to be treated with iodine 131 30mCi will be invited to join the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Chao-Chun Huang

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2017

First Posted

November 21, 2017

Study Start

November 1, 2017

Primary Completion

August 31, 2018

Study Completion

December 31, 2019

Last Updated

February 23, 2022

Record last verified: 2017-11

Locations

TW(1)