Breast NeoplasmsNCT05339113
Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma
A study testing 68Ga-FAPI-46 PET/CT in people with Breast Neoplasms and Positron Emission Tomography, run by The National Center of Oncology, Azerbaijan at 1 site in Azerbaijan.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Neoplasms, Positron Emission Tomography, Fibroblast Activation Protein Inhibitor
- What is being tested?
- 68Ga-FAPI-46 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAzerbaijan
- Study dates
- 4 Feb 2021to Dec 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Azerbaijan1 site, 1 recruiting
- Recruiting
National Centre of Oncology
Baku, AZ1011
Fuad Novruzov, MD PhD, +994 50 335 09 44, drnovruzov@gmail.com
About this study
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.
Read the 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.
- Conditions
- Breast Neoplasms, Positron Emission Tomography, Fibroblast Activation Protein Inhibitor, Fluorodeoxyglucose F18
- Being tested
- 68Ga-FAPI-46 PET/CT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-46 PET/CTDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI-46 PET/CT + 18-FDG PET/CT | Experimental | 18FDG PET/CT scan is followed by [68Ga]FAPI-46 PET/CT within 2-3 days. Receives: Diagnostic Test: 68Ga-FAPI-46 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2-3 days
Secondary outcomes (4)
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
Measured: 2 days
SUVmax for metastatic lymph nodes
SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT
Measured: 2 days
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
Measured: 2 days
Correlation between tumor SUVmax values and pathology grade
Correlation between tumor SUVmax values and pathology grade calculated
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start4 Feb 2021
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The National Center of Oncology, Azerbaijan
- Sponsor type
- Other government
- Collaborators
- SOFIE INC
- Responsible party
- Principal investigator, Fuad Novruzov, The National Center of Oncology, Azerbaijan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339113
- Sponsor's protocol ID
- NCO-21001
- Status last verified
- Jun 2022
- First submitted
- 14 Apr 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No