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

Primary Purpose

Graves' Disease

Status

Unknown status

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Low dose of I-131

Intermediate dose

High dose

About this trial

This is an interventional treatment trial for Graves' Disease focused on measuring radioiodine therapy, Graves' disease, Hyperthyroidism, calculated dose

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-65 hyperthyroid patients (Graves'disease)

Exclusion Criteria:

Pregnancy or lactation

Sites / Locations

Nuclear Medicine Research Center, Ghaem HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Low dose of I-131

Intermediate dose

High dose

Arm Description

Patients with Graves' disease who will be treated with I-131, using 100 microcurie per gram (uCi/gr) of thyroid weight

Patients with Graves' disease who will be treated with 150 microcurie (uCi) of I-131 per gram of thyroid weight.

Patients with Graves' disease who will be treated with I-131 using 200 uCi/gr of thyroid weight.

Outcomes

Primary Outcome Measures

change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month

thyroid-stimulating hormone (TSH), T4, T3

Secondary Outcome Measures

Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy

Hypothyroidism index

Full Information

NCT ID

NCT02114619

First Posted

April 12, 2014

Last Updated

April 14, 2014

Sponsor

Mashhad University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02114619

Brief Title

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

Official Title

The Effect of Different Calculated Doses of I-131 in Treatment of Patients With Grave's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Graves' Disease

Keywords

radioiodine therapy, Graves' disease, Hyperthyroidism, calculated dose

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low dose of I-131

Arm Type

Active Comparator

Arm Description

Patients with Graves' disease who will be treated with I-131, using 100 microcurie per gram (uCi/gr) of thyroid weight

Arm Title

Intermediate dose

Arm Type

Active Comparator

Arm Description

Patients with Graves' disease who will be treated with 150 microcurie (uCi) of I-131 per gram of thyroid weight.

Arm Title

High dose

Arm Type

Active Comparator

Arm Description

Patients with Graves' disease who will be treated with I-131 using 200 uCi/gr of thyroid weight.

Intervention Type

Drug

Intervention Name(s)

Low dose of I-131

Intervention Description

We wil administer 100 micro currie of iodine per thyroid gram

Intervention Type

Drug

Intervention Name(s)

Intermediate dose

Intervention Description

We will administer 150 micro currie of iodine per thyroid gram

Intervention Type

Drug

Intervention Name(s)

High dose

Intervention Description

We will administer 200 micro currie of iodine per thyroid gram

Primary Outcome Measure Information:

Title

change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month

Description

thyroid-stimulating hormone (TSH), T4, T3

Time Frame

1,3,6,12 month

Secondary Outcome Measure Information:

Title

Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy

Description

Hypothyroidism index

Time Frame

1,3,6,12 month

Other Pre-specified Outcome Measures:

Title

Change of thyroid volume

Description

Change of thyroid volume 1,3,6 and 12 months after therapy using ultrasonography

Time Frame

1,3,6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-65 hyperthyroid patients (Graves'disease) Exclusion Criteria: Pregnancy or lactation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Seyed Rasoul Zakavi, MD. IBNM

Phone

+98-511 8012799

Zakavir@mums.ac.ir

First Name & Middle Initial & Last Name or Official Title & Degree

Narjess Ayati, MD. FEBNM

Phone

+98-511 8012782

Ayatin@mums.ac.ir

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Narjess Ayati, MD, FEBNM

Organizational Affiliation

Nuclear Medicine Research Center

Official's Role

Study Director

Facility Information:

Facility Name

Nuclear Medicine Research Center, Ghaem Hospital

City

Mashhad

State/Province

Khorasan-Razavi

ZIP/Postal Code

9919991766

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zohre Mousavi, MD. IBE

Phone

+98-5118599359

Mosaviz@mums.ac.ir

First Name & Middle Initial & Last Name & Degree

Ramin Sadeghi, MD. IBNM

First Name & Middle Initial & Last Name & Degree

Seyed Rasoul Zakavi, MD. IBNM

12. IPD Sharing Statement

Learn more about this trial

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

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