Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma

Conditions
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Breast Neoplasms, Positron Emission Tomography, Fibroblast Activation Protein Inhibitor, Fluorodeoxyglucose F18

Intervention / Treatment
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* Diagnostic Test: 68Ga-FAPI-46 PET/CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-FAPI-46 PET/CT + 18-FDG PET/CT<br>18FDG PET/CT scan is followed by [68Ga]FAPI-46 PET/CT within 2-3 days. | Diagnostic Test: 68Ga-FAPI-46 PET/CT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2-3 days | 
| Best diagnostic imaging time of 68GaFAPI-46 PET/CT | Tumor-to-background ratio values measured over the 10th, 30th and 60th minute scan time | 2-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 days | 
| SUVmax for metastatic lymph nodes | SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT | 2 days | 
| 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 | 2 days | 
| Correlation between tumor SUVmax values and pathology grade | Correlation between tumor SUVmax values and pathology grade calculated | 2 days |