Breast CancerNCT06916338
Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer
An observational study of Breast Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
This study aims to evaluate the diagnostic accuracy (sensitivity, specificity, positive/negative predictive value, and overall accuracy) of 18F-FAPI-04 PET imaging in breast cancer for detecting fibroblast activation protein (FAP)-rich lesions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 18F-FAPI-04 PET scan
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2025to Dec 2027
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study aims to enroll 30 patients aged 18-75 years with clinically or pathologically confirmed breast cancer or suspected recurrence/metastasis, including both early-stage (I-II) and advanced-stage (III-IV) cases. The primary objective is to evaluate the diagnostic and therapeutic monitoring value of 18F-FAPI-04 PET for identifying primary tumors, metastatic lesions, and assessing treatment response. Exclusion criteria include: concurrent malignancies (except non-breast malignancies cured >5 years prior), severe hepatic or renal dysfunction, and pregnancy.
Who may be able to join
- Age 18-75 years old, any gender;
- Clinically or pathologically confirmed diagnosis of breast cancer, or suspected recurrence/metastasis;
- Presence of at least 1 measurable lesion (RECIST 1.1 criteria);
- ECOG score 0-2 and expected survival ≥ 12 weeks;
- Laboratory markers are met:
- Blood count: WBC ≥4.0×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L Liver and kidney function: ALT/AST ≤ 2.5 × ULN, SCr ≤ 1.5 × ULN;
- Signed informed consent.
Who cannot join
- Major surgery or trauma within 4 weeks;
- Severe infection, liver or kidney insufficiency;
- History of allergies (developer components);
- Pregnant/nursing female or not using effective contraception;
- Inability to co-operate with PET (e.g. claustrophobia);
- Any other situation that researchers considered it unsuitable to participate in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
This study aims to evaluate the diagnostic accuracy (sensitivity, specificity, positive/negative predictive value, and overall accuracy) of 18F-FAPI-04 PET imaging in breast cancer for detecting fibroblast activation protein (FAP)-rich lesions. Additionally, the study will longitudinally monitor dynamic changes in FAP expression levels and tumor size during therapy, including chemotherapy, targeted therapy, or immunotherapy.The non-invasive nature of 18F-FAPI-04 PET addresses limitations of traditional biopsy-dependent stromal evaluation, offering whole-body quantification of tumor microenvironment dynamics to optimize therapeutic decision-making.
Read the detailed description
Breast cancer diagnosis and treatment continue to face challenges in adequately assessing tumor heterogeneity and dynamically monitoring therapeutic responses. Traditional biopsy-dependent pathological analysis is limited by its invasive nature, sampling bias, and inability to repeatedly sample tissues, making it difficult to capture the spatiotemporal heterogeneity of cancer-associated fibroblasts (CAFs) within the systemic tumor microenvironment (TME). Fibroblast activation protein (FAP), a core marker of CAFs, plays a critical role in tumor proliferation, metastasis, immune evasion, and drug resistance, with its expression levels significantly correlating with patient prognosis. However, current imaging techniques, such as 18F-FDG PET, primarily reflect tumor metabolic activity and lack sufficient sensitivity for detecting FAP-positive lesions with low metabolism but high aggressiveness. They also fail to differentiate post-therapy inflammatory responses from residual tumor activity. 18F-FAPI-04 PET overcomes these biological limitations of conventional imaging by precisely targeting FAP, enabling non-invasive molecular visualization of systemic lesions. Its high target-to-background ratio allows detection of early-stage micrometastases (e.g., lymph node or bone metastases), addressing the risk of missed diagnoses with FDG PET. Furthermore, by quantifying dynamic changes in FAP expression, it enables real-time monitoring of therapy-induced stromal remodeling (e.g., CAF depletion post-immunotherapy or pro-fibrotic responses post-chemotherapy), providing critical insights into resistance mechanisms and treatment efficacy prediction.
This study aims to evaluate the diagnostic performance (sensitivity, specificity, predictive values, accuracy) of 18F-FAPI-04 PET imaging in breast cancer. Additionally, it will monitor dynamic changes in FAP expression and tumor size during therapy, providing insights for patient stratification, clinical staging, treatment response assessment, early detection of resistance, and recurrence/metastasis, ultimately guiding personalized therapeutic strategies.
- Conditions
- Breast Cancer
- Being tested
- 18F-FAPI-04 PET scan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAPI-04 PET scanRadiation
FAPI-04, labeled with PET radio-nuclide 18F will be used as a molecular imaging tracer for PET scan. All participants will undergo 18F-FAPI-04 PET scan.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FAPI-04 PET scan | Not described Receives: Radiation: 18F-FAPI-04 PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start11 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Weifang People's Hospital, Zibo Central Hospital, Qianfoshan Hospital, Jining Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916338
- Sponsor's protocol ID
- QDFY-NM-25001
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 29 Apr 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 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer
- ClinicalTrials.gov ID
- NCT06916338
- Acronym / sponsor ID
- QDFY-NM-25001
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Weifang People's Hospital, Zibo Central Hospital, Qianfoshan Hospital, Jining Medical University
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Apr 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 aims to evaluate the diagnostic accuracy (sensitivity, specificity, positive/negative predictive value, and overall accuracy) of 18F-FAPI-04 PET imaging in breast cancer for detecting fibroblast activation protein (FAP)-rich lesions. Additionally, the study will longitudinally monitor dynamic changes in FAP expression levels and tumor size during therapy, including chemotherapy, targeted therapy, or immunotherapy.The non-invasive nature of 18F-FAPI-04 PET addresses limitations of traditional biopsy-dependent stromal evaluation, offering whole-body quantification of tumor microenvironment dynamics to optimize therapeutic decision-making.
Detailed description
Breast cancer diagnosis and treatment continue to face challenges in adequately assessing tumor heterogeneity and dynamically monitoring therapeutic responses. Traditional biopsy-dependent pathological analysis is limited by its invasive nature, sampling bias, and inability to repeatedly sample tissues, making it difficult to capture the spatiotemporal heterogeneity of cancer-associated fibroblasts (CAFs) within the systemic tumor microenvironment (TME). Fibroblast activation protein (FAP), a core marker of CAFs, plays a critical role in tumor proliferation, metastasis, immune evasion, and drug resistance, with its expression levels significantly correlating with patient prognosis. However, current imaging techniques, such as 18F-FDG PET, primarily reflect tumor metabolic activity and lack sufficient sensitivity for detecting FAP-positive lesions with low metabolism but high aggressiveness. They also fail to differentiate post-therapy inflammatory responses from residual tumor activity. 18F-FAPI-04 PET overcomes these biological limitations of conventional imaging by precisely targeting FAP, enabling non-invasive molecular visualization of systemic lesions. Its high target-to-background ratio allows detection of early-stage micrometastases (e.g., lymph node or bone metastases), addressing the risk of missed diagnoses with FDG PET. Furthermore, by quantifying dynamic changes in FAP expression, it enables real-time monitoring of therapy-induced stromal remodeling (e.g., CAF depletion post-immunotherapy or pro-fibrotic responses post-chemotherapy), providing critical insights into resistance mechanisms and treatment efficacy prediction.
This study aims to evaluate the diagnostic performance (sensitivity, specificity, predictive values, accuracy) of 18F-FAPI-04 PET imaging in breast cancer. Additionally, it will monitor dynamic changes in FAP expression and tumor size during therapy, providing insights for patient stratification, clinical staging, treatment response assessment, early detection of resistance, and recurrence/metastasis, ultimately guiding personalized therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FAPI-04 PET scan | – | Radiation: 18F-FAPI-04 PET scan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study aims to enroll 30 patients aged 18-75 years with clinically or pathologically confirmed breast cancer or suspected recurrence/metastasis, including both early-stage (I-II) and advanced-stage (III-IV) cases. The primary objective is to evaluate the diagnostic and therapeutic monitoring value of 18F-FAPI-04 PET for identifying primary tumors, metastatic lesions, and assessing treatment response. Exclusion criteria include: concurrent malignancies (except non-breast malignancies cured >5 years prior), severe hepatic or renal dysfunction, and pregnancy.
Key inclusion criteria (7 listed)
- Age 18-75 years old, any gender;
- Clinically or pathologically confirmed diagnosis of breast cancer, or suspected recurrence/metastasis;
- Presence of at least 1 measurable lesion (RECIST 1.1 criteria);
- ECOG score 0-2 and expected survival ≥ 12 weeks;
- Laboratory markers are met:
Key exclusion criteria (6 listed)
- Major surgery or trauma within 4 weeks;
- Severe infection, liver or kidney insufficiency;
- History of allergies (developer components);
- Pregnant/nursing female or not using effective contraception;
- Inability to co-operate with PET (e.g. claustrophobia);
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 |
|---|---|---|
| 18F-FAPI-04 PET scanFAPI-04, labeled with PET radio-nuclide 18F will be used as a molecular imaging tracer for PET scan. All participants will undergo 18F-FAPI-04 PET scan. | Radiation | 18F-FAPI-04 PET scan |
Primary outcome
SUV
Time frame: 2 years
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET
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 29 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 7 inclusion and 6 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 29 Apr 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 China. 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 Zhenguang Wang (＋86-0532-82913318, wangzhenguang@qde.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV (time frame: 2 years). 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 29 Apr 2025.