Clinical Study of 18F-Labeled FAPI-04 in PET Imaging of Breast Cancer

NCT06916338 | Recruiting

• 1 other identifier: QDFY-NM-25001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• SUV

  The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET

  2 years

Study Arms (1)

18F-FAPI-04 PET scan

Radiation: 18F-FAPI-04 PET scan

Interventions

18F-FAPI-04 PET scan RADIATION

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.

18F-FAPI-04 PET scan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• Weifang People's Hospital: collaborator
• Zibo Central Hospital: collaborator
• Qianfoshan Hospital: collaborator
• Jining Medical University: collaborator

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhenguang Wang

CONTACT

＋86-0532-82913318; wangzhenguang@qde.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 11, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)