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

Not Applicable

• Conditions: Fluorodeoxyglucose F18; Breast Neoplasms; Fibroblast Activation Protein Inhibitor; Positron Emission Tomography
• Interventions: Diagnostic Test: 68Ga-FAPI-46 PET/CT

• Registration Number: NCT05339113
• Lead Sponsor: The National Center of Oncology, Azerbaijan

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.

Study Timeline

• Study Start: 2021-02-04
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-21
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-24
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI-46 PET/CT + 18-FDG PET/CT	68Ga-FAPI-46 PET/CT	18FDG PET/CT scan is followed by \[68Ga\]FAPI-46 PET/CT within 2-3 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
SUVmax for metastatic lymph nodes	2 days	SUVmax 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
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
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

Trial Locations

Locations (1)

National Centre of Oncology; 🇦🇿 Baku, Azerbaijan