Protocol summary
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Study aim
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Diagnostic, Determination of HER2 status in primary and metastatic lesions in Breast Cancer
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Inclusion:Female; Primary breast cancer; Size greater than 2cm;
Without any history of biopsy
Exclusion:Renal failure; Liver dysfunction; Pregnancy; Lactation
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Intervention groups
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This is a preliminary diagnostic study for imaging of HER2 positive breast cancer by a newly designed radio-peptide
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Main outcome variables
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Radiotracer uptake by breast cancer; Distribution of radiopeptide in other tissues; Specificity; Sensitivity; Negative predictive value; Positive predictive value; Accuracy
General information
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Reason for update
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For pharmacokinetic and dosimetry studies, the number of samples needs to be changed from 20 to 25.
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Acronym
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IRCT registration information
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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
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Registration date
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2018-03-21, 1397/01/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-05-22, 1397/03/01
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Expected recruitment end date
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2019-05-22, 1398/03/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical evaluation of the SSSLTVPWY peptide labeled with 99m TC to determine HER2 status for the treatment of patients with Breast Cancer
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Public title
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Clinical evaluation of the SSSLTVPWY peptide labeled with 99m TC
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Purpose
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Diagnostic
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Inclusion/Exclusion criteria
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Inclusion criteria:
Female
Primary breast cancer
Size greater than 2cm
Without any history of biopsy
Exclusion criteria:
Renal failure
Liver dysfunction
Pregnancy
Lactation
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
25
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-03-06, 1396/12/15
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Ethics committee reference number
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IR.MAZUMS..REC.1396.1155
Health conditions studied
1
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Description of health condition studied
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breast cancer
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ICD-10 code
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C50.91
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ICD-10 code description
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Malignant neoplasm of breast of unspecified site, female
Primary outcomes
1
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Description
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Radiotracer uptake by breast cancer
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Timepoint
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Imaging of the breast at 1,2,3 and 4 hours after the administration of the Radiopeptide
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Method of measurement
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With imaging
Secondary outcomes
1
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Description
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Distribution of radiopeptide in other tissues
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Timepoint
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Imaging at 1,2,3 and 4 hours after the administration of the radiopeptide
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Method of measurement
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With imaging
Intervention groups
1
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Description
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Intervention group: imaging at 1,2,3 and 4 hours after the intravenous injection of 740 MBq of radiopeptide
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Category
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Diagnosis
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available