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

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05339113

NCO-21001

Ages 18-90
Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

participants with non-malignant lesions;
participants with pregnancy;
the inability or unwillingness of the research participant, parent or legalrepresentative to provide written informed consent.

Study Design

February 04, 2021

December 31, 2022

Study 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.

Connect with a study center

National Centre of Oncology
Baku, AZ1011
Azerbaijan
Active - Recruiting

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