Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 4, 2021
CompletedFirst Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJune 24, 2022
June 1, 2022
1.6 years
April 14, 2022
June 21, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (4)
Diagnostic efficacy for breast carcinomas
2 days
SUVmax for metastatic lymph nodes
2 days
Diagnostic efficacy for metastatic lymph nodes
2 days
Correlation between tumor SUVmax values and pathology grade
2 days
Study Arms (1)
68Ga-FAPI-46 PET/CT + 18-FDG PET/CT
EXPERIMENTAL18FDG PET/CT scan is followed by \[68Ga\]FAPI-46 PET/CT within 2-3 days.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The National Center of Oncology, Azerbaijanlead
- SOFIE INCcollaborator
Study Sites (1)
National Centre of Oncology
Baku, AZ1011, Azerbaijan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Nuclear Medicine Department
Study Record Dates
First Submitted
April 14, 2022
First Posted
April 21, 2022
Study Start
February 4, 2021
Primary Completion
September 1, 2022
Study Completion
December 1, 2022
Last Updated
June 24, 2022
Record last verified: 2022-06