Purpose: Determining the Efficacy of radioactive Iodide plaques:
Inclusion and exclusion keys: All the patients with uveal melanoma not treatable with Ruthenium plaques will include. All the patients with unwillingness to continuing the project, pregnancy, lactation will be excluded from the study.
Sample size: 10-15 consecutive patients.
the contribution and its time and consequences: After the diagnosis, the iodide plaque will be implanted under the lesion on sclera as soon as it is made and after the predetermined time will be explanted. Then the patient will be followed up in the following months for evaluating any decreasing in the thickness and resorption of subretinal fluid. The stability of the thickness and/or its decreasing is the main outcome of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091929875N1
Registration date:2016-10-05, 1395/07/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-05, 1395/07/14
Registrant information
Name
Fariba Ghassemi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5540 0010
Email address
ghasemi_f@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Atomic energy agency and Tehran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of radioactive iodide 125 made in Iran in uveal melanoma
Public title
Using radioactive iodide 125 in uveal melanoma
Purpose
Treatment
Inclusion/Exclusion criteria
INCLUSION: All the patients with uveal melanoma that are not the candidates for ruthenium plaques and un-acception of the enucleation by the patient.
Exclusion: Unwillingness of the patient for continuing the study, pregnancy and nursing.
Age
From 18 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences ethics committee
Street address
Number 1 building of Tehran University of Medical Sciences, Keshavarz Boulvard, Qods street
City
Tehran
Postal code
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
IR.TUMS.REC.1395.2742
Health conditions studied
1
Description of health condition studied
Uveal melanoma
ICD-10 code
C69.3
ICD-10 code description
Choroid
Primary outcomes
1
Description
Decrease in the thickness of tumor
Timepoint
At 4 months
Method of measurement
ultrasound and clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
This intervention will be undertaken as implantation of Iodide radioactive plaque under the ocular tumor on sclera, for a measured time, according to the thickness of the tumor.
After this period of time, the plaque will be removed and the patient will be followed.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Fariba Ghassemi
Street address
Farabi Hospital, South Kargar street, Qazvin Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Younesian
Street address
Farabi Hospital, South Kargar, Qazvin square
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran University of Medical Sciences
Full name of responsible person
Fariba Ghassemi
Position
Associate professor- MD
Other areas of specialty/work
Street address
Farabi Hospital, South Kargar street, Qazvin Square
City
Tehran
Postal code
Phone
+98 21 5540 0010
Fax
Email
ghasemi_f@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Ghassemi
Position
Associate professor/ MD
Other areas of specialty/work
Street address
Farabi Hospital, South Kargar, Qazvin Square
City
Tehran
Postal code
Phone
+98 21 5540 0010
Fax
Email
ghasemi_f@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Ghassemi
Position
Associate Professor- MD
Other areas of specialty/work
Street address
Farabi Hospital, South Kargar, Qazvin Square
City
Tehran
Postal code
1336616351
Phone
+98 21 5540 0010
Fax
Email
ghasemi_f@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)