Evaluating 18F-FAPI-04 PET Imaging for Breast Cancer Detection
Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer
This study is testing a new type of PET imaging to see if it can help find breast cancer more accurately and track how tumors change during treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Affiliated Hospital of Qingdao University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Qingdao, Shandong) |
| Trial ID | NCT06916338 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic accuracy of 18F-FAPI-04 PET imaging in identifying fibroblast activation protein (FAP)-rich lesions in breast cancer patients. It will monitor changes in FAP expression levels and tumor size during various therapies, including chemotherapy and immunotherapy. By providing a non-invasive alternative to traditional biopsies, this study seeks to enhance the understanding of tumor microenvironment dynamics and improve therapeutic decision-making.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with confirmed breast cancer or suspected recurrence/metastasis and at least one measurable lesion.
Not a fit: Patients with severe infections, significant organ insufficiency, or those unable to cooperate with PET imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and non-invasive methods for diagnosing and monitoring breast cancer.
How similar studies have performed: While the use of FAP-targeted imaging is a novel approach, similar studies have shown promise in enhancing cancer detection and monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-75 years old, any gender; 2. Clinically or pathologically confirmed diagnosis of breast cancer, or suspected recurrence/metastasis; 3. Presence of at least 1 measurable lesion (RECIST 1.1 criteria); 4. ECOG score 0-2 and expected survival ≥ 12 weeks; 5. 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; 6. Signed informed consent. Exclusion Criteria: 1. Major surgery or trauma within 4 weeks; 2. Severe infection, liver or kidney insufficiency; 3. History of allergies (developer components); 4. Pregnant/nursing female or not using effective contraception; 5. Inability to co-operate with PET (e.g. claustrophobia); 6. Any other situation that researchers considered it unsuitable to participate in the trial.
Where this trial is running
Qingdao, Shandong
- The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Zhenguang Wang
- Email: wangzhenguang@qde.edu.cn
- Phone: ＋86-0532-82913318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.