To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)

• Sponsor: Hanlim Pharm. Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04606329
• Collaborator: (none)
• Enrollment: 109
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 17.3

Study Details

Study Description

Brief Summary

This study is a multicenter, Randomized, Open-label, Parallel, Phase 3 Clinical Trial in 8 weeks for screening, once Investigational product injection, Follow up visit.

Condition or Disease	Intervention/Treatment	Phase
Breast Diseases	Drug: LuminoMark inj.(Conc. for fluorescence); Drug: Charcotrace Inj.	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jul 20, 2020
• Actual Primary Completion Date: Jan 28, 2021
• Actual Study Completion Date: Jan 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LuminoMark inj. Injection LuminoMark inj. 0.2mL once in this study.	Drug: LuminoMark inj.(Conc. for fluorescence); Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
Active Comparator: Charcotrace Inj. Charcotrace Inj. about 0.3~1mL	Drug: Charcotrace Inj.; Injection Charcotrace Inj. about 0.3~1mL once in this study.

Outcome Measures

Primary Outcome Measures

1. Negative Resection margin rate [Visit 5 (Day 14 ~Day 24)]

   The presence or absence of margin involvement in the resected breast lesions

Secondary Outcome Measures

1. Technical success rate [Visit 3 (Day 0)]

   The proportion of colored lesion when make an incision

2. Coloring confirmation rate of excision lesion [Visit 3 (Day 0)]

   The proportion of colored excision lesion

3. Pathologic perfection [Visit 5 (Day 14 ~Day 24)]

   Pathologic perfection is how well the surgeon removed the lesion compared to an identified by gross pathologic method. Visit 5, Investigators calculate 'Pathologic perfection' using by the 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]

4. Pigmentation rate [Visit 5 (Day 14 ~Day 24)]

   Check whether skin is pigmented or not

5. Re-operation rate [Visit 5 (Day 14 ~Day 24)]

   The number of subjects who need re-operation is evaluated based on the investigator's comprehensive judgment including histopathology test results.

6. Procedure complication rate [Visit 4, 5 (Day 1, Day 14 ~Day 24)]

   Evaluate the numbers of subjects with procedure complication after lesion removal

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

• Hanlim Pharm. Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanlim Pharm. Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04606329
• Other Study ID Numbers: HL_LMN_301
• First Posted: Oct 28, 2020
• Last Update Posted: Feb 10, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hanlim Pharm. Co., Ltd.: Nonpalpable Breast Lesions
• Additional relevant MeSH terms: Breast Diseases

Study Results

No Results Posted as of Feb 10, 2021