Comparative Study of Different I-131 Doses in Graves' Dis... | NCT02114619

Studies
Comparative Study of Different I-131 Doses in Graves' Disease

NCT02114619

Sponsor

Mashhad University of Medical Sciences

Status

Unknown status

Last Update Posted

Apr 15, 2014Estimated

Enrollment

450Estimated

Phase

Not Applicable

Conditions

Graves' Disease

Interventions

Low dose of I-131
Intermediate dose
High dose

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Apr 12, 2014

First Submission Date that Met QC Criteria

Apr 14, 2014

First Posted Date

Apr 15, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2014

Last Update Posted Date

Apr 15, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

S.R.ZAKAVI, Head of Nuclear Medicine Research Center, Mashhad University of Medical SciencesPrincipal Investigator

Lead Sponsor

Mashhad University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Radioactive iodine (RAI) administration is an effective and completely established treatment modality in hyperthyroidism including Graves' disease. Despite the long experience with radioiodine for hyperthyroidism, controversy remains regarding the optimal dose of iodine that is required to achieve long-term euthyroidism. The fixed activity administration method does not optimize the therapy, giving often too high or too low radiation to the gland, but the optimal dose per gram of thyroid mass in calculated activity administration method is also under much debates. This prospective study has been designed in order to compare the effect of different calculated doses of radioiodine on Graves' disease treatment outcome.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low dose of I-131	Active Comparator	Patients with Graves' disease who will be treated with I-131, using 100 microcurie per gram (uCi/gr) of thyroid weight	Drug: Low dose of I-131
Intermediate dose	Active Comparator	Patients with Graves' disease who will be treated with 150 microcurie (uCi) of I-131 per gram of thyroid weight.	Drug: Intermediate dose
High dose	Active Comparator	Patients with Graves' disease who will be treated with I-131 using 200 uCi/gr of thyroid weight.	Drug: High dose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low dose of I-131	Drug	We wil administer 100 micro currie of iodine per thyroid gram	Low dose of I-131

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month	thyroid-stimulating hormone (TSH), T4, T3	1,3,6,12 month

Secondary Outcomes

Measure	Description	Time Frame
Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy	Hypothyroidism index	1,3,6,12 month

Other Outcomes

Measure	Description	Time Frame
Change of thyroid volume	Change of thyroid volume 1,3,6 and 12 months after therapy using ultrasonography	1,3,6 and 12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-65 hyperthyroid patients (Graves'disease)

Exclusion Criteria:

Pregnancy or lactation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seyed Rasoul Zakavi, MD. IBNM	Contact	+98-511 8012799		Zakavir@mums.ac.ir
Narjess Ayati, MD. FEBNM	Contact	+98-511 8012782		Ayatin@mums.ac.ir

Overall Officials

Name	Affiliation	Role
Narjess Ayati, MD, FEBNM	Nuclear Medicine Research Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nuclear Medicine Research Center, Ghaem Hospital	Recruiting	Mashhad	Razavi Khorasan Province	9919991766	Iran

Condition Browse Module

MeSH Terms

ID	Term
D006111	Graves Disease
D006980	Hyperthyroidism

Ancestor Terms

ID	Term
D005094	Exophthalmos
D009916	Orbital Diseases
D005128	Eye Diseases
D006042	Goiter

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000614965	Iodine-131

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided