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A trial to evaluate the investigational device used for early prediction of response to neoadjuvant chemotherapy in breast cancer patients using Discrete Multi-Wavelength Near Infra-Red Spectroscopy (DMW-NIRS)

A single-center, exploratory investigator initiated trial to evaluate the effectiveness and safety of investigational device used for early prediction of response to neoadjuvant chemotherapy in breast cancer patients using Discrete Multi-Wavelength Near Infra-Red Spectroscopy (DMW-NIRS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008798
Enrollment
60
Registered
2023-09-15
Start date
2023-11-23
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

None listed

Interventions

Medical Device : Patients diagnosed with invasive breast cancer who meet the study inclusion criteria and do not have exclusion criteria will be included as a single group. The test device will be mea

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Korean women over 19 years old and under 79 years old (as of the date of signing the consent form) 2) Patients with invasive breast cancer confirmed by biopsy 3) When surgery is planned after receiving neoadjuvant chemotherapy 4) If the patient voluntarily agree to participate after receiving a sufficient explanation about the study 5) If the patient have the will and ability to implement the procedures specified in the research plan

Exclusion criteria

Exclusion criteria: 1) Women who may be pregnant or who are pregnant or lactating 2) If the measurement area has a mole, significant trauma or scar, or is suffering from mastitis 3) If the patient have a history of previous surgery for breast disease 4) If the patient have a breast implant or foreign body injected 5) When measurement is difficult due to pus coming out of the location of the lesion or skin deformation 6) Bilateral breast cancer or benign lesions in normal area 7) Metastatic breast cancer (stage IV) 8) If the patient have a history of photo allergy 9) In cases where participation in this study is deemed impossible by the medical judgment of the researcher (e.g., severe mental anxiety, physical weakness)

Design outcomes

Primary

MeasureTime frame
Changes in tumor size and chromophores

Secondary

MeasureTime frame
Safety: Any unfavorable medical findings resulting in symptoms not observed prior to study

Countries

Korea, Republic of

Contacts

Public ContactEun Young Chae

Asan Medical Center

chaeey@gmail.com+82-2-3010-1709

Outcome results

None listed

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