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Clinical Study of PEM (Positron Emission Mammography)-DOT (Diffuse Optical Tomography) Fusion Imaging System

Clinical Study of PEM (Positron Emission Mammography)-DOT (Diffuse Optical Tomography) Fusion Imaging System

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046167
Enrollment
Unknown
Registered
2021-05-07
Start date
2021-07-01
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Breast Cancer

Interventions

Sponsors

The First Affiliated Hospital of the Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years; 2. Gender: female; 3. Diagnosed by clinicopathology; 4. 30 breast cancer patients who plan to receive neoadjuvant chemotherapy; 5. 10 patients with benign space-occupying breast lesions but with other high-risk factors for tumors or unexplained increase in tumor markers; 6. After discussion by MDT, PET/CT examination is deemed necessary; 7. The length of the lesion is >= 0.5 cm; 8. In the prone position, the drooping length of the breast of the lesion exceeds 5 cm; 9. The size of both breasts is less than or equal to E cup, which can be included in the equipment; 10. Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Minors, pregnant women, and lactating women; 2. Severe liver and kidney dysfunction (alanine aminotransferase is 8-10 times the upper limit of normal, and serum creatinine is 186-442umol/L); 3. A history of drug allergy or a drug has been stopped due to adverse reactions when using a drug; 4. Patients who have had serious adverse reactions when using imaging agents.

Design outcomes

Primary

MeasureTime frame
Standard uptake value (SUV);Oxygen saturation of blood;

Countries

China

Contacts

Public ContactKang Fei

The First Affiliated Hospital of the Air Force Medical University

fmmukf@qq.com+86 13991365070

Outcome results

None listed

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