A Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark inj. Versus Charcotrace inj. in Patients with Nonpalpable Breast Lesions

A Multicenter, Randomized, Open-label, Parallel Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark inj. Versus Charcotrace inj. in Patients with Nonpalpable Breast Lesions

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0006123

Enrollment

108

Registered

2021-05-07

Start date

2020-06-03

Completion date

Unknown

Last updated

2021-05-24

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

Conditions

None listed

Interventions

Drug : Inject Investigational product once in this study during Visit 2 or Visit 3 for the enrolled patients. The Investigator injects a Investigational product in subcutanous corresponding to each gr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 19 years = age = 80 years 2) Those who have lesion vial mammography and breast ultrasound 3) Those who be expected to do operation about non palpable breast lesion excision 4) Written consent voluntarily to participate in this clinical trial

Exclusion criteria

Exclusion criteria: 1) Patients who be expected to do mastectomy 2) Patients with multiple tumor or diffuse microcalcification 3) Patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection 4) Patients who were treated with moderate to severe radiotherapy 5) Patients who were treated with neoadjuvant Chemotherapy 6) Patients with active invading skin connective tissue disease 7) Patients with local progressing breast cancer or inflammatory local progressing breast cancer 8) Patients who have an allergy to investigational product or any of the component with the Investigational product 9) Patients who disagree about contraception for this clinical trial 10) A pregnant women or lactating women 11) Patients who participated in other clinical trials within the past 12 weeks from the date of informed consent 12) Patients who investigators determines unsuitable for this clinical trial

Design outcomes

Primary

Measure	Time frame
Negative Resection margin rate	—

Secondary

Measure	Time frame
Technical success rate;Coloring confirmation rate of excision lesion ;Pathologic perfection : the longest diameter of measured lesion by gross(=visual) pathologic method / the longest diameter of removed lesion after surgery;Pigmentation rate;Re-operation rate ;Procedure complication rate	—

Countries

Korea, Republic of

Contacts

Public ContactSeokwon Kim

Samsung Medical Center

seokwon1.kim@samsung.com+82-2-3410-2375

Outcome results