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Research on the accuracy of 18F-FAPI-42 PET-CT in diagnosing borderline and malignant phyllode tumors of the breast

Research on the accuracy of 18F-FAPI-42 PET-CT in diagnosing borderline and malignant phyllode tumors of the breast

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085686
Enrollment
Unknown
Registered
2024-06-17
Start date
2024-06-17
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline and malignant phyllodes tumor of breast

Interventions

Gold Standard:1. Pathological examination confirms that the lesion is a metastatic tumor. 2. For lesions that cannot obtain pathology, from an imaging perspective, persistent lesions that do not respo
Index test:18F-FAPI is a imaging agent for intravenous injection, with a dosage of 0.8-1.5mCi/kg. Within 45-60 minutes after administration, PET-CT (which is a routine equipment in the hospital and do

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18 to 75; 2. Diagnosed as borderline or malignant PT patient after puncture or partial resection biopsy; 3. Clinical laboratory tests (liver, kidney, and blood) within normal range, or abnormal without clinical significance Meaning (NCS), or abnormalities with clinical significance (CS), but do not affect PET-CT imaging, biopsy, or the implementation of surgery; 4. The Eastern Oncology Collaborative Group (ECOG) scale scores physical fitness = 0-2 points; 5. According to the guidelines of the Clinical Research Ethics Committee, provide an informed consent form (by participants, parents, or legal representatives) patients who have been signed and agreed by the designated representative.

Exclusion criteria

Exclusion criteria: 1. Severe diseases that combine non malignant tumors will affect patient compliance or put patients at risk state; 2. Pregnant or breastfeeding female patients; 3. Allergies to imaging agents and drugs; 4. Dementia, intellectual disabilities, or any mental illness that hinders the understanding of informed consent forms; 5. Claustrophobia or other mental illnesses that affect PET-CT examination; 6. The researchers believe that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
18F-FAPI-42 PET-CT detection rate (sensitivity);

Secondary

MeasureTime frame
18F-FAPI-42 PET-CT specificity;18F-FDG PET-CT sensitivity;18F-FDG PET-CT specificity;SUV value of the lesion (standard uptake value of imaging drugs by the lesion);The expression fibroblast activating protein (FAP) in the lesion;

Countries

China

Contacts

Public ContactYan Nie

SunYat-Sen Memorial Hospital, SunYat-Sen University

nieyan7@mail.sysu.edu.cn+86 158 7653 5276

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026