Ablation of the thyroid residue with I-131 after thyroidectomy is performed in the management of patients with differentiated thyroid cancers but there is no confidence over using lower or higher doses. We aimed this study to determine whether low doses of I-131 (30 mCi) could provide acceptable therapeutic results as comparing with optimal 100 mCi I-131 for ablating of thyroid residue after total/near total thyroidectomy. More patient's radiation and biological damages are noticed in higher doses and conversely ineffective treatment may be considered in lower doses of radioiodine therapy. 341 patients with low risk differentiated thyroid carcinoma (without evidence of capsular/vascular/lymphatic invasion or distant metastases) were randomly allocated into group A (30mCi) and B (100mCi). Thyroglobuline (Tg), Thyroid stimulating hormone (TSH) and anti-Tg were measured and also thyroid bed sonography, whole body scan (WBS) and plannimetry of the scans were carried out for all patients before and 6 months after I-131 therapy. Patients’ response to the therapy was evaluated based on post-treatment WBS and Tg values. Absent uptake in thyroid bed and Tg value less than 4ng/ml were considered as complete response. The rate of treatment response in group A and B were compared with Chi square test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706171100N2
Registration date:2011-08-16, 1390/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-16, 1390/05/25
Registrant information
Name
Davood Beiki
Name of organization / entity
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 3333
Email address
beikidav@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2005-06-18, 1384/03/28
Expected recruitment end date
2008-10-19, 1387/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial for the evaluation of the efficacy of 30 mCi versus 100 mCi, 131I for ablation of residual thyroid tissue
Public title
Comparison between low and high doses of radioactive iodine in the treatment of thyroid cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with differentiated thyroid carcinoma (DTC): without any history of ablation therapy; with no palpable mass in the neck; with no evidence of capsular; vascular or lymph node invasion. Exclusion criteria: Any area of I-131 uptake in post-treatment whole body scan; Failing to follow the patients.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
341
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz boulevard, Ghods str.
City
Tehran
Postal code
Approval date
2004-06-14, 1383/03/25
Ethics committee reference number
132.2131
Health conditions studied
1
Description of health condition studied
Diffrentiated Thyroid Cancer
ICD-10 code
C73
ICD-10 code description
Malignant neoplasm of thyroid gland
Primary outcomes
1
Description
Response to treatment with I-131
Timepoint
6 Months
Method of measurement
Tg, AntiTg tests and whole body scan with I-131
Secondary outcomes
1
Description
disease recurrence
Timepoint
6 and 12 months
Method of measurement
Lab measurements, sonography and clinical assessment
Intervention groups
1
Description
Low dose (30 mCi)
Category
Treatment - Drugs
2
Description
High dose (100 mCi) of I-131
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Babak Fallahi
Street address
Research Institute for Nuclear Medicine, Shariati Hospital, N Kargar Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Keshavarz boulevard
City
Tehran
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Babak Fallahi
Position
Associate Professor of Nuclear Medicine
Other areas of specialty/work
Street address
Shariati Hospital, N Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8863 3333
Fax
+98 21 8802 6905
Email
bfallahi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Babak Fallahi
Position
Associate Professor of Nuclear Medicine
Other areas of specialty/work
Street address
Shariati Hospital, N Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8863 3334
Fax
+98 21 8802 6905
Email
bfallahi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Institute for Nuclear Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Davood Beiki
Position
Associate Professor of Nuclear Pharmacy
Other areas of specialty/work
Street address
Shariati Hospital, N Kargar Ave.
City
Tehran
Postal code
Phone
Fax
Email
beikidav@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)