The diagnostic efficacy of 99mTc-FAPI SPECT/CT in the diagnosis of malignant tumors
Design
This interventional clinical trial with a single group design of 20 patients, will be performed between Agust 2023 and March 2025.
Settings and conduct
Patients with inclusion criteria are selected and justified in the nuclear medicine center of the Emam Reza Hospital at Bushehr. The consent form is obtained. The diagnosis will be performed with intravenous injection of 99mTc-FAPI and imaging will perform 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:IRCT20240626062262N1
Registration date:2024-07-04, 1403/04/14
Registration timing:prospective
Last update:2024-07-04, 1403/04/14
Update count:0
Registration date
2024-07-04, 1403/04/14
Registrant information
Name
Sahar Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 901 203 4200
Email address
rezaei.s@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-21, 1403/05/31
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Detection of Malignant Tumors with Radiopharmaceutical Tc-99m FAPI and SPECT imaging
Public title
Detection of Malignant Tumors with Radiopharmaceutical Tc-99m FAPI and SPECT imaging
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
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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 Tabrizi University of Medical Sciences
Street address
Golgasht Street, Tabriz, Iran
City
Tbriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2023-10-02, 1402/07/10
Ethics committee reference number
IR.TBZMED.REC.1402.511
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
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
Intervention groups
1
Description
Intervention group: 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, Emam Reza Hospital
Full name of responsible person
Sahar Rezaei
Street address
Golgasht Street, Tabriz, Iran
City
Tbriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3336 2504
Email
saharrezaei.tums@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Golgasht Street, Tabriz, Iran
City
Tbriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 7310
Email
shahabip@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Esmaeil Gharepapagh
Position
Associate Professor of Nuclear Medicine
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
Golgasht Street, Tabriz, Iran
City
Tbriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3336 2504
Email
esmaeil.gharepapagh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sahar Rezaei
Position
Assistant Professor of Medical Physics
Latest degree
Ph.D.
Other areas of specialty/work
Nuclear Medicine
Street address
Golgasht Street, Tabriz, Iran
City
Tbriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3336 2504
Email
saharrezaei.tums@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sahar Rezaei
Position
Assistant Professor of Medical Physics
Latest degree
Ph.D.
Other areas of specialty/work
Nuclear Medicine
Street address
Golgasht Street, Tabriz, Iran
City
Tbriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3336 2504
Email
saharrezaei.tums@gmail.com
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