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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05339113
Other study ID # NCO-21001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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