Breast Neoplasms, Fibroblast Activation Protein Inhibitor, Fluorodeoxyglucose F18, Positron Emission Tomography
Conditions
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.
Interventions
DIAGNOSTIC_TEST68Ga-FAPI-46 PET/CT
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.
Sponsors
SOFIE INC
The National Center of Oncology, Azerbaijan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum standardised uptake value [SUVmax] for primary lesion | 2-3 days | 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 | 2-3 days | Tumor-to-background ratio values measured over the 10th, 30th and 60th minute scan time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic efficacy for breast carcinomas | 2 days | 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 | 2 days | SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT |
| Diagnostic efficacy for metastatic lymph nodes | 2 days | 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 | 2 days | Correlation between tumor SUVmax values and pathology grade calculated |
Countries
Azerbaijan
Contacts
Primary ContactFuad Novruzov, MD PhD
Outcome results
None listed