Determination of HER2 receptor status in primary and metastatic lesions in patient with breast cancer
Design
Two hundred female patients with breast cancer who filled the inclusion criteria will enroll in this study. Patient will be received radiolabeled peptide, initially planer images are taken from whole body and breast region of patient. After four hours, the SPECT image is taken of thoracic region. After nuclear imaging process, patient will be referred for breast lesion biopsy to determination of HER2 status by Immunohistochemistry and other conventional diagnostic testes as law. At the end of study, the provided images will be compared with Immunohistochemistry result as a gold standard to determine the specificity, sensitivity, negative predictive value, positive predictive value and accuracy of test. In previous similar study, it was performed on 20 patients, while the present study will perform on 250 patients.
Settings and conduct
The 99mTc-SSSLTVPWY peptide is used for determining HER2 status in patients with breast cancer. The site of the study is Fatemeh Al zahra hospital in Sari. After injection of radiolabeled peptide, the planar images of total body and breast region are taken as well as the SPECT mode. The images will be matched with the results of the immunohistochemistry method. This study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion: Female; primary breast cancer; without any history of biopsy Exclusion: Renal failure; liver dysfunction; pregnancy; Lactation
Intervention groups
This is a diagnostic study for imaging of breast cancer and HER2 assessment using a radiolabeled peptide.
Main outcome variables
Radiotracer uptake by breast cancer site and other tissue
Specificity, sensitivity, negative predictive value, positive predictive value, accuracy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141006019423N3
Registration date:2024-05-25, 1403/03/05
Registration timing:prospective
Last update:2024-05-25, 1403/03/05
Update count:0
Registration date
2024-05-25, 1403/03/05
Registrant information
Name
Seyed Jalal Hosseinimehr
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 4308
Email address
sjhosseinim@mazums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2027-08-23, 1406/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Phase III clinical study of 99mTc-labeled peptide for imaging and HER2 assessment in patients with breast cancer
Public title
The study of 99mTc-radiolabeled peptide for breast cancer imaging
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Female
breast cancer
Without biopsy history
Exclusion criteria:
Age
From 20 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
250
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
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moalem Square, Research Deputy, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2023-07-12, 1402/04/21
Ethics committee reference number
IR.MAZUMS.REC.1402.171
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.91
ICD-10 code description
Malignant neoplasm of breast of unspecified site, female
Primary outcomes
1
Description
Radiotracer uptake by breast cancer
Timepoint
Imaging of the breast at 1,2,3 and 4 hours after the administration of the radiolabeled peptide
Method of measurement
Imaging
2
Description
Distribution of radiolabeled peptide in other tissues
Timepoint
Imaging at 1,2,3 and 4 hours after the administration of the radiolabeled peptide
Method of measurement
Imaging
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Imaging at 1,2,3 and 4 hours after the intravenous injection of 740 MBq of radiopeptide
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Al Zahra Hospital
Full name of responsible person
Dr. Seyed Mohammad Abedi
Street address
Army Blvd., Imam Hossein Square
City
Sari
Province
Mazandaran
Postal code
4818813371
Phone
+98 911 323 2273
Email
mabedi167@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahimnejad
Street address
Research Deputyو Moalem Square
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 912 257 4155
Email
sjhosseinim@yahoo.com
Grant name
Grant code / Reference number
17646
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
2
Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Dr. Younes Panahi
Street address
No. 21, Besat Street, West Fatemi, NIMAD Building
City
Tehran
Province
Tehran
Postal code
Phone
+98 21 6693 8037
Email
NIMAD@RESEARCH.AC.IR
Grant name
Grant code / Reference number
۴۰۲۱۴۳۸
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
Proportion provided by this source
70
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Seyed Jalal Hosseinimehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nuclear Pharmacy
Street address
17 Khazar Bulv. Mazandaran University of Medical Sciences, Faculty of Pharmacyacy, Faculty of Pharmacy
City
Sari
Province
Mazandaran
Postal code
48471-93698
Phone
+98 11 3354 4308
Email
sjhosseinim@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Seyed Jalal Hosseinimehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nuclear Pharmacy
Street address
Khazar Street, Mazandaran University of Medical Science
City
Sari
Province
Mazandaran
Postal code
48471-93698
Phone
+98 11 3354 4308
Email
sjhosseinim@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Seyed Jalal hosseinimehr
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nuclear Pharmacy
Street address
Faculty of Pharmacy, Khazar Street, Mazandaran University of Medical Science
City
Sari
Province
Mazandaran
Postal code
48471-93698
Phone
+98 11 3354 4308
Email
sjhosseinim@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of this study will be submitted as a manuscript to an international journal for publication.
When the data will become available and for how long
The results will be available after publication.
To whom data/document is available
All interesting person can access to data in article.
Under which criteria data/document could be used
No.
From where data/document is obtainable
Access to full paper
What processes are involved for a request to access data/document