Clinical trial NCT03743259: To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions
Official title: A Multicenter, Open-label, Parallel, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark Inj. (Conc. for Fluorescence) Localization in Patients With Nonpalpable Breast Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Diseases
Keywords: Nonpalpable Breast Lesions
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 44
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 weeks for screening, once Investigational product injection, Follow up visit.

Detailed description: The purpose of this study is to evaluate the efficacy and safety of LuminoMark inj. (Conc. for fluorescence) localization in patients with nonpalpable breast lesions.

Eligibility criteria: Inclusion Criteria:

1. Female, 19 years ≤ age ≥ 80 years
2. Those who be expected to do operation about non palpable breast lesion excision
3. Those who have lesion vial mammography and breast ultrasound
4. Written consent voluntarily to participate in this clinical trial

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

Primary outcomes:
measure: Excision perfection(It is a formula. This formula's calculation method is as follows. [Excision perfection = the longest diameter of removed lesion after surgery / the longest diameter of identified lesion via breast ultrasonography results])
timeFrame: Visit 3(Day 0)
Secondary outcomes:
measure: Coloring confirmation rate of excision lesion.
timeFrame: Visit 3(Day 0)
measure: Technical success rate
timeFrame: Visit 3(Day 0)
measure: Pathologic perfection(It is a formula. This formula's calculation method is as follows. [Pathologic perfection = the longest diameter of measured lesion by gross(=visual) pathologic method / the longest diameter of removed lesion after surgery])
timeFrame: Visit 3(Day 0)
measure: Pigmentation
timeFrame: Visit 5(Day 10~Day 24)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Seok Won Kim, PI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim I, Choi HJ, Ryu JM, Lee SK, Yu JH, Lee JE, Nam SJ, Shin HJ, Kim SW. The efficacy and safety of indocyanine green-hyaluronic acid mixture (LuminoMark) for localization in patients with non-palpable breast lesions: a multi-center open-label parallel phase-2 clinical trial. BMC Surg. 2021 Mar 16;21(1):134. doi: 10.1186/s12893-021-01129-y.