The diagnostic efficacy of 99mTc-FAPI SPECT/CT in the diagnosis of malignant tumors
Design
This is an interventional clinical trial with a single group design of 15 patients, performing between February 2022 and March 2023.
Settings and conduct
Patients with inclusion criteria are selected and justified in the nuclear medicine center of the Khalij-e-Fars Hospital at Bushehr. The consent form is obtained. The diagnosis will be performed with intravenous injection of 99mTc-FAPI and imaging was performed at different 1 and 4 hours post-injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Volunteering to participate in clinical trials and signing an informed consent form, Patients with suspected or newly diagnosed or previously treated malignant tumors, Inconclusive findings on imaging modalities.
Exclusion criteria: Pregnant and lactating women, the inability or unwillingness of the participant, parent, or legal representative to provide written informed consent.
Intervention groups
In this trial, 740 MBq of the 99mTc-FAPI will be injected intravenously. Then, SPECT/CT imaging will be performed at 1 and 4 h after tracer administration of radiotracer.
Main outcome variables
Target/Background ratio of 99mTc-FAPI in the diagnosis of malignancies.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210612051548N5
Registration date:2022-01-29, 1400/11/09
Registration timing:prospective
Last update:2022-01-29, 1400/11/09
Update count:0
Registration date
2022-01-29, 1400/11/09
Registrant information
Name
Majid Assadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 0361
Email address
assadipoya@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficiency of 99mTc-FAPI radiotracer in diagnosis of patients suffering from cancer
Public title
Diagnostic efficacy of 99mTc-FAPI SPECT/CT
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteering to participate in clinical trials and signing an informed consent form (signed by participant, parent, or legal representative)
Patients with suspected or new diagnosed or previously treated malignant tumors
Inconclusive findings on imaging modalities.
Exclusion criteria:
Pregnant and lactating women
The inability or unwillingness of the research participant, parent, or legal representative to provide written informed consent
Age
From 18 years old
Gender
Both
Phase
1
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
Research Ethics Committees of Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Science, Moallem Street
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.BPUMS.REC.1400.056
Health conditions studied
1
Description of health condition studied
Malignant neoplasm
ICD-10 code
C00-C96
ICD-10 code description
Malignant neoplasm
Primary outcomes
1
Description
Target/Background ratio of 99mTc-FAPI SPECT/CT in Diagnosis of malignancies.
Timepoint
99mTc-FAPI Imaging at 1and 4 hours after the administration of the Radiotracer.
Method of measurement
SPECT/CT scanner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The majority of epithelial tumors recruit fibroblasts and other non‐malignant cells and activate them into cancer‐associated fibroblasts. This often leads to overexpression of the membrane serine protease fibroblast‐activating protein (FAP). It has already been shown that DOTA‐bearing FAP inhibitors (FAPIs) generate high contrast images with PET/CT scans. Since SPECT is a lower cost and more widely available alternative to PET, 99mTc‐labeled FAPIs represent attractive tracers for imaging applications in a larger number of patients. In this clinical trial, 740 MBq of the 99mTc-FAPI will be injected intravenously. Then, SPECT/CT will be performed at 1 and 4 h after tracer administration of radiotracer.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Nuclear Medicine Center, Khalig-e-Fars Hospital
Full name of responsible person
Majid Assadi
Street address
Khalig-e-Fars Hospital, Taleghani Street
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Email
assadipoya@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Vice-Chancellor for Research and Technology of Bushehr University of Medical Sciences, Salman-e-Farsi Blvd, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3345 0178
Fax
Email
khamisipourgholamreza@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Majid Assadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
The Khalij-e-Fars Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
assadipoya@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Majid Assadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
The Khalij-e-Fars Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
assadipoya@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Narges Jokar
Position
Research Instructor
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
The Khalij-e-Fars Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
narges.jokar69@gmail.com
Web page address
https://pgnmrc.bpums.ac.ir/fa/index.aspx
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available