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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of [68Ga]GaFAPI-46 PET/CT and [18F]FDG PET/CT Findings in Breast Carcinoma
- ClinicalTrials.gov ID
- NCT05339113
- Acronym / sponsor ID
- NCO-21001
- Conditions
- Breast Neoplasms, Positron Emission Tomography, Fibroblast Activation Protein Inhibitor, Fluorodeoxyglucose F18
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The National Center of Oncology, AzerbaijanOther government
- Collaborators
- SOFIE INC
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI-46 PET/CT + 18-FDG PET/CT | Experimental | Diagnostic Test: 68Ga-FAPI-46 PET/CT18FDG PET/CT scan is followed by [68Ga]FAPI-46 PET/CT within 2-3 days. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPI-46 PET/CTPatients 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. | Diagnostic test | 68Ga-FAPI-46 PET/CT + 18-FDG PET/CT |
Primary outcome
Maximum standardised uptake value [SUVmax] for primary lesion
Time frame: 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
Time frame: 2-3 days
Tumor-to-background ratio values measured over the 10th, 30th and 60th minute scan time
4 secondary outcomes
Diagnostic efficacy for breast carcinomas
Time frame: 2 days
SUVmax for metastatic lymph nodes
Time frame: 2 days
Diagnostic efficacy for metastatic lymph nodes
Time frame: 2 days
Correlation between tumor SUVmax values and pathology grade
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Azerbaijan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fuad Novruzov, MD PhD (+994 50 335 09 44, drnovruzov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum standardised uptake value [SUVmax] for primary lesion (time frame: 2-3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.