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General information
20
25
2025
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For pharmacokinetic and dosimetry studies, the number of samples needs to be changed from 20 to 25.
For pharmacokinetic and dosimetry studies, the number of samples needs to be changed from 20 to 25.
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برای انجام مطالعات فارماکوکینتیک و دوزیمتری، نیاز است تعداد نمونه ها از 20 به 25 افزایش یابد.
برای انجام مطالعات فارماکوکینتیک و دوزیمتری، نیاز است تعداد نمونه ها از 20 به 25 افزایش یابد.
Protocol summary
Study aim
Diagnostic, Determination of HER2 status in primary and metastatic lesions in Breast Cancer
Design
20 patients with breast cancer who filled the inclusion criteria and accept to precipitate in this study initially designed for HER 2 imaging in spot and whole body and also SPECT modes and then referred for breast lesion biopsy to determination of HER2 status by Immunohistochemistry and other conventional diagnostic testes as law. In the end of study we compared the provided images with Immunohistochemistry result as a gold standard to determine the specificity, sensitivity, negative predictive value, positive predictive value and accuracy of test.
Settings and conduct
The SSSLTVPWY peptide labeled with 99mTc to determine HER2 status for the treatment of patients with Breast Cancer; The site of the study is Fatemeh Al zahra hospital in Sari, after the injection of Radiopeptide the imaging in point and total body, as well as the SPECT mode, is performed and the images are matched with the results of the immunohistochemistry method. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion:Female; Primary breast cancer; Size greater than 2cm;
Without any history of biopsy
Exclusion:Renal failure; Liver dysfunction; Pregnancy; Lactation
Intervention groups
This is a preliminary diagnostic study for imaging of HER2 positive breast cancer by a newly designed radio-peptide
Main outcome variables
Radiotracer uptake by breast cancer; Distribution of radiopeptide in other tissues; Specificity; Sensitivity; Negative predictive value; Positive predictive value; Accuracy
General information
Reason for update
For pharmacokinetic and dosimetry studies, the number of samples needs to be changed from 20 to 25.
Acronym
IRCT registration information
IRCT registration number:IRCT20180310039019N1
Registration date:2018-03-21, 1397/01/01
Registration timing:prospective
Last update:2019-12-19, 1398/09/28
Update count:2
Registration date
2018-03-21, 1397/01/01
Registrant information
Name
Javad Biabani ardakani
Name of organization / entity
The University of mazandaran
Country
Iran (Islamic Republic of)
Phone
+98 11 3368 5510
Email address
javadbiabani@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the SSSLTVPWY peptide labeled with 99m TC to determine HER2 status for the treatment of patients with Breast Cancer
Public title
Clinical evaluation of the SSSLTVPWY peptide labeled with 99m TC
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Female
Primary breast cancer
Size greater than 2cm
Without any history of biopsy