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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05339113
• Other study ID #: NCO-21001
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2021
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: The National Center of Oncology, Azerbaijan
• Contact: Fuad Novruzov, MD PhD
• Phone: +994 50 335 09 44
• Email: drnovruzov[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Positron Emission Tomography

Intervention

Diagnostic Test:
• 68Ga-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.

Locations

Country	Name	City	State
Azerbaijan	National Centre of Oncology	Baku

Sponsors (2)

Lead Sponsor	Collaborator
The National Center of Oncology, Azerbaijan	SOFIE INC

Country where clinical trial is conducted

Azerbaijan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	SUVmax for metastatic lymph nodes	SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT	2 days
Secondary	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
Secondary	Correlation between tumor SUVmax values and pathology grade	Correlation between tumor SUVmax values and pathology grade calculated	2 days