1.Introduction of a new imaging technique for HER2-positive metastatic lesions of breast cancer using trastuzumab-labeled radiopharmaceutical.
2.Presentation a future treatment of HER2-positive metastatic breast cancer lesions with beta-emitting radiopharmaceuticals.
Design
Patients in a group of 22 are randomly injected with a radiopharmaceutical and then imaged.
Settings and conduct
The radiopharmaceutical is produced by Pars Isotope Company. Patients are selected and justified in the oncology clinic or the office of Professor Amir Hossein Emami, and if they wish, they are referred to the nuclear medicine center of Imam Khomeini Hospital. In the nuclear medicine center of Imam Khomeini Hospital, a consent form is obtained and then an injection is conducted and finally, imaging is performed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patient with metastatic breast cancer and HER2 receptor
Over 18 years old
Stage 4
No previous treatment with Herceptin
Negative estrogen and progesterone receptors
Exclusion Criteria:
Pregnant patients
Patients who do not have appropriate heart function
Intervention groups
Imaging is performed after the injection of 10 to 13 mcg of copper 64 (radioactive material) labeled trastuzumab.
Main outcome variables
Uptake of copper 64 labeled trastuzumab within known metastatic lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180818040823N2
Registration date:2020-12-23, 1399/10/03
Registration timing:prospective
Last update:2020-12-23, 1399/10/03
Update count:0
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
Mehrshad Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2405
Email address
meabbasi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of a diagnostic radiopharmaceutical (64Cu-DOTA-Trastuzumab) in patients with metastatic breast cancer and HER2-positive
Public title
Application of labeled trastuzumab to diagnose breast cancer in HER2 positive cases
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with metastatic breast cancer and HER2 receptor
stage 4
No previous treatment with Herceptin
Negative estrogen and progesterone receptors
Exclusion criteria:
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
22
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 Science
Street address
Research office, 1st floor, block NO1 of medical science faculty, Poorsina St , Qods St, Enghelab Sq.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.TUMS.MEDICINE.REC.98.758
Health conditions studied
1
Description of health condition studied
Metastatic breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Uptake of radiopharmaceutical in lesions
Timepoint
At imaging time (60 minutes after injection)
Method of measurement
Observation and semi-quantification using SUV
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, 5 mg of 64Cu-DOTA-trastuzumab radiopharmaceutical with a dose of 500-300 MB / h MBq, is injected into 22 patients with metastatic breast cancer and HER2 receptor. Then PET imaging is performed in 3 intervals, 1 h, 24 h day, and 48 h after injection. The drug is supplied by Pars Isotope Company.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Mehrshad Abbasi
Street address
Nuclear Medicine Department, Imam Khomeini Hospital Complex, Dr. Qarib street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6657 5102
Email
meabbasi@tums.ac.ir
Web page address
2
Recruitment center
Name of recruitment center
Cancer Institute, Imam Khomeini Hospital Complex
Full name of responsible person
Amirhosein Emami
Street address
Cancer Institute, Imam Khomeini Hospital Complex, Dr. Qarib street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6657 5102
Email
emami@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohamadali Sahraiyan
Street address
Vice-Chancellor for Research and Technology, sixth floor, Central University Organization, Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6670 6142
Email
msahrai@sina.tums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrshad Abbasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Nuclear Medicine Department, Imam Khomeini Hospital Complex, Dr. Qarib street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6657 5102
Email
meabbasi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrshad Abbasi
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Nuclear Medicine Department, Imam Khomeini Hospital Complex, Dr. Qarib street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
002166575102
Email
meabbasi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrshad Abbasi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Nuclear Medicine Department, Imam Khomeini Hospital Complex, Dr. Qarib street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6657 5102
Email
meabbasi@tums.ac.ir
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The sharable data are de-identified images of patients with this new diagnostic method and performed quantitative and qualitative analyzes
When the data will become available and for how long
The access period will start 6 months after the results are published
To whom data/document is available
Both academics and non-faculty medical staff will be able to use it.
Under which criteria data/document could be used
The de-identified images of the patients will be available by email to the principal investigator and can be applied by those who need access.
From where data/document is obtainable
For more images and data than what has been published as an article, applicants can contact the principal researcher via email.
What processes are involved for a request to access data/document
An initial response will be given up to 24 hours later after sending the email, and according to the type of applied information, the applicant will be provided with the applied data for up to 1 month.