Back to resultsComparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma
Primary Purpose
Breast Neoplasms, Positron Emission Tomography, Fibroblast Activation Protein Inhibitor
Status
Recruiting
Phase
Not Applicable
Locations
Azerbaijan
Study Type
Interventional
Intervention
68Ga-FAPI-46 PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
- adult participants (aged 18 years or order);
- participants with newly diagnosed breast carcinoma;
- pathology confirmed by lesion tru-cut biopsy;
- participants who were able to provide informed consent.
Exclusion Criteria:
- participants with non-malignant lesions;
- participants with pregnancy;
- the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Sites / Locations
- National Centre of OncologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-FAPI-46 PET/CT + 18-FDG PET/CT
Arm Description
18FDG PET/CT scan is followed by [68Ga]FAPI-46 PET/CT within 2-3 days.
Outcomes
Primary Outcome Measures
Maximum standardised uptake value [SUVmax] for primary lesion
SUVmax of 68Ga-FAPI PET/CT for breast carcinoma in comparison with SUVmax value of 18F-FDG PET/CT
Best diagnostic imaging time of 68GaFAPI-46 PET/CT
Tumor-to-background ratio values measured over the 10th, 30th and 60th minute scan time
Secondary Outcome Measures
Diagnostic efficacy for breast carcinomas
Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of 68Ga-FAPI PET/CT for breast carcinomas in comparison with 18F-FDG PET/CT
SUVmax for metastatic lymph nodes
SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT
Diagnostic efficacy for metastatic lymph nodes
Sensitivity, specificity, accuracy, PPV and NPV of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT
Correlation between tumor SUVmax values and pathology grade
Correlation between tumor SUVmax values and pathology grade calculated
Full Information
NCT ID
NCT05339113
First Posted
April 14, 2022
Last Updated
June 21, 2022
Sponsor
The National Center of Oncology, Azerbaijan
Collaborators
SOFIE INC
1. Study Identification
Unique Protocol Identification Number
NCT05339113
Brief Title
Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma
Official Title
Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The National Center of Oncology, Azerbaijan
Collaborators
SOFIE INC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to compare the diagnostic performance of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT in primary and metastatic lesions of breast cancer and to reveal the best diagnostic imaging time of 68Ga-FAPI-46 PET/CT.
Detailed Description
Participants with breast carcinoma will undergo contemporaneous 18F-FDG and 68Ga-FAPI PET/CT. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT will be calculated and compared to evaluate the diagnostic efficacy. In addition, best diagnostic imaging time of 68Ga-FAPI-46 PET/CT will be evaluated at 10th, 30th and 60th minute scan time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Positron Emission Tomography, Fibroblast Activation Protein Inhibitor, Fluorodeoxyglucose F18
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-FAPI-46 PET/CT + 18-FDG PET/CT
Arm Type
Experimental
Arm Description
18FDG PET/CT scan is followed by [68Ga]FAPI-46 PET/CT within 2-3 days.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-FAPI-46 PET/CT
Intervention Description
Patients are scanned 10 minute, 30 minute and 1 hour after 68Ga-FAPI-46 as well as one hour 18-FDG injection within 2-3 days interval.
Primary Outcome Measure Information:
Title
Maximum standardised uptake value [SUVmax] for primary lesion
Description
SUVmax of 68Ga-FAPI PET/CT for breast carcinoma in comparison with SUVmax value of 18F-FDG PET/CT
Time Frame
2-3 days
Title
Best diagnostic imaging time of 68GaFAPI-46 PET/CT
Description
Tumor-to-background ratio values measured over the 10th, 30th and 60th minute scan time
Time Frame
2-3 days
Secondary Outcome Measure Information:
Title
Diagnostic efficacy for breast carcinomas
Description
Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of 68Ga-FAPI PET/CT for breast carcinomas in comparison with 18F-FDG PET/CT
Time Frame
2 days
Title
SUVmax for metastatic lymph nodes
Description
SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT
Time Frame
2 days
Title
Diagnostic efficacy for metastatic lymph nodes
Description
Sensitivity, specificity, accuracy, PPV and NPV of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT
Time Frame
2 days
Title
Correlation between tumor SUVmax values and pathology grade
Description
Correlation between tumor SUVmax values and pathology grade calculated
Time Frame
2 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult participants (aged 18 years or order);
participants with newly diagnosed breast carcinoma;
pathology confirmed by lesion tru-cut biopsy;
participants who were able to provide informed consent.
Exclusion Criteria:
participants with non-malignant lesions;
participants with pregnancy;
the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuad Novruzov, MD PhD
Phone
+994 50 335 09 44
Email
drnovruzov@gmail.com
Facility Information:
Facility Name
National Centre of Oncology
City
Baku
ZIP/Postal Code
AZ1011
Country
Azerbaijan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuad Novruzov, MD PhD
Phone
+994 50 335 09 44
Email
drnovruzov@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma
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