Breast Cancer InvasiveFAPI-PETNCT06790264
Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer
A study testing 68Ga-FAPi-46 PET/CT in people with Breast Cancer Invasive and Node Positive Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
This study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Invasive, Node Positive Breast Cancer
- What is being tested?
- 68Ga-FAPi-46 PET/CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed, biopsy proven breast cancer;
- Diagnosis of invasive breast cancer;
- Tumor diameter more than 2 centimeters;
- Radiological evidence of axillary nodes involvement;
- 18F-FDG PET/CT performed as baseline diagnostic procedure, during routine diagnostic work-up;
- 68Ga-FAPi-46 PET/CT performed within 4 weeks from 18F-FDG PET/CT;
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- Patients suitable to primary treatment (surgery or neo-adjuvant therapy);
- 68Ga-FAPi-46 PET/CT performed within 8 weeks from primary treatment;
- Female patients;
- Age ≥18;
- Willing to sign informed consent form.
Who cannot join
- Pregnant or nursing patients;
- Unable to stay flat and cannot tolerate PET scan;
- Sample tissue from biopsy unavailable for assessing Fibroblast Activation Protein (FAP) expression;
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, Italy, 20141
Francesco Ceci, +390257489315, francesco.ceci@ieo.it
About this study
Official title: Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer. a Phase II Study to Evaluate the Comparison of 68Ga-FAPi-46 and 18F-FDG Uptake in Patients with Different Breast Cancer Subtypes
This study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to primary therapy.
Read the detailed description
All patients affected by newly diagnosed, clinically N-positive BC that have already undergone a baseline 2-deoxy-2-[fluorine-18]fluoro-D-glucose (18F-FDG) PET/CT (T1) will be screened for eligibility. Patients who will meet all inclusion/exclusion criteria will be considered eligible and asked to participate to the study after signing the informed consent form. Patients' eligibility will be evaluated by the referent nuclear medicine physician (T2). Considering the clinical experience of the investigators, we expect to complete patient enrolment in 12 months after study accrual
- Being tested
- 68Ga-FAPi-46 PET/CT
- Keywords
- 68Ga-FAPi-46 PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPi-46 PET/CTProcedure or surgery
Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPi-46 PET/CT | Experimental | Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT Receives: Procedure: 68Ga-FAPi-46 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT positivity rate
Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT of positivity rate (percentage of detection of metastatic patients)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Nov 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer InvasiveStudies 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
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Ceci, MD, Principal investigator, European Istitute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790264
- Sponsor's protocol ID
- UID 4047
- Acronym
- FAPI-PET
- Status last verified
- Dec 2024
- First submitted
- 17 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer. a Phase II Study to Evaluate the Comparison of 68Ga-FAPi-46 and 18F-FDG Uptake in Patients with Different Breast Cancer Subtypes
- ClinicalTrials.gov ID
- NCT06790264
- Acronym / sponsor ID
- FAPI-PET / UID 4047
- Keywords
- 68Ga-FAPi-46 PET/CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 24 Jan 2025 (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.
This study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to primary therapy.
Detailed description
All patients affected by newly diagnosed, clinically N-positive BC that have already undergone a baseline 2-deoxy-2-[fluorine-18]fluoro-D-glucose (18F-FDG) PET/CT (T1) will be screened for eligibility. Patients who will meet all inclusion/exclusion criteria will be considered eligible and asked to participate to the study after signing the informed consent form. Patients' eligibility will be evaluated by the referent nuclear medicine physician (T2). Considering the clinical experience of the investigators, we expect to complete patient enrolment in 12 months after study accrual
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 | Experimental | Procedure: 68Ga-FAPi-46 PET/CTStudy participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Newly diagnosed, biopsy proven breast cancer;
- Diagnosis of invasive breast cancer;
- Tumor diameter more than 2 centimeters;
- Radiological evidence of axillary nodes involvement;
- 18F-FDG PET/CT performed as baseline diagnostic procedure, during routine diagnostic work-up;
Key exclusion criteria (4 listed)
- Pregnant or nursing patients;
- Unable to stay flat and cannot tolerate PET scan;
- Sample tissue from biopsy unavailable for assessing Fibroblast Activation Protein (FAP) expression;
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
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/CTStudy participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT | Procedure or surgery | 68Ga-FAPi-46 PET/CT |
Primary outcome
Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT positivity rate
Time frame: 3 months
Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT of positivity rate (percentage of detection of metastatic patients)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Francesco Ceci, MD principal investigator
European Istitute of Oncology
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 Cancer Invasive and Node Positive Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
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 11 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Ceci (+390257489315, francesco.ceci@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT positivity rate (time frame: 3 months). 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 27 Jan 2025; AzTrials last refreshed its copy on 30 Oct 2026.