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

The National Center of Oncology, Azerbaijan

Status

Enrolling

Conditions

Fibroblast Activation Protein Inhibitor

Breast Neoplasms

Fluorodeoxyglucose F18

Positron Emission Tomography

Treatments

Diagnostic Test: 68Ga-FAPI-46 PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT05339113

NCO-21001

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.