Clinical study on the diagnostic efficacy of DOBI dynamic optical breast imaging system in breast tumor

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200057216

Enrollment

Unknown

Registered

2022-03-04

Start date

2022-02-09

Completion date

Unknown

Last updated

2023-10-09

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

Conditions

Breast tumor

Interventions

Gold Standard:Pathological diagnosis and follow-up information

Index test:After scanning and acquiring images with DOBI dynamic optical breast (targeting function) imaging system, intelligent assisted reading software (DOBI_Score) was used to realize automatic id

Eligibility

Sex/Gender

Female

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Female breast outpatients or inpatients over 18 years old; 2. Already had ultrasound or mammography/breast MRI at the center.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating subjects; 2. The subject cannot maintain a fixed and sustained posture during the examination; 3. Subject has infectious skin lesions (e.g., psoriasis, eczema); 4. The subject has a history of silicone allergy; 5. Breast with open wound, abrasion and active bleeding; 6. The skin surface of the breast has ulceration, edema area more than 1/4 of the whole breast and armor chest; 7. Subjects who have undergone breast surgery within 3 months; 8. Subjects with mental disorders who are not fully informed.

Design outcomes

Primary

Measure	Time frame
DOBI Score;	—

Countries

China

Contacts

Public ContactYang Yaping, Wu Wei

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

yangyap2@mail.sysu.edu.cn+86 18026278616

Outcome results

None listed

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