Evaluating 18F-FAPI-04 PET Imaging for Breast Cancer Detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.