Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03743259
Other study ID # HL_LMN_201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 29, 2018
Est. completion date April 22, 2019

Study information

Verified date January 2019
Source Hanlim Pharm. Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date April 22, 2019
Est. primary completion date January 11, 2019
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LuminoMark inj. 0.1mL
Injection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study.
LuminoMark inj. 0.2mL
Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
Charcotrace Inj.
Injection Charcotrace Inj. about 0.3~1mL once in this study.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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]) Excision perfection is how well the surgeon removed the lesion compared to an identified by breast ultrasonography. Visit 3, Investigators calculate 'Excision perfection' using by the formula. Visit 3(Day 0)
Secondary Coloring confirmation rate of excision lesion. The proportion of colored excision lesion Visit 3(Day 0)
Secondary Technical success rate The proportion of colored lesion when make an incision Visit 3(Day 0)
Secondary 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]) Pathologic perfection is how well the surgeon removed the lesion compared to an identified by gross pathologic method. Visit 3, Investigators calculate 'Pathologic perfection' using by the formula. Visit 3(Day 0)
Secondary Pigmentation Check whether skin is pigmented or not Visit 5(Day 10~Day 24)
See also
  Status Clinical Trial Phase
Recruiting NCT04854304 - Abbreviate or FAST Breast MRI for Supplemental Breast Cancer Screening for Black Women at Average Risk and Dense Breasts
Recruiting NCT01678170 - Clinical Application of Breast Blood-oxygen Functional Imaging Technology N/A
Completed NCT00039780 - Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel Phase 3
Completed NCT02909452 - Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT04535466 - Diagnosis Predictive Modle for Dense Density Breast Tissue Based on Radiomics
Recruiting NCT01917279 - Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC Phase 3
Recruiting NCT01427400 - The Use of Botulinum Toxin A in Two-Stage Tissue Expander/ Implant Breast Reconstruction Phase 4
Completed NCT05665894 - Vacuum-Assisted Evacuation (VAE) Of Symptomatic and/or Voluminous Breast Haematomas Following Surgeries And Percutaneous Procedures: a Retrospective Analysis
Not yet recruiting NCT04088110 - Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer Phase 2
Terminated NCT02997540 - Effect of Body Position and Probe Position on the Localization of Breast Mass
Terminated NCT01140776 - Clinical Evaluation of OSNA Breast Cancer System in Breast Cancer Patients Receiving Neoadjuvant Therapy N/A
Recruiting NCT04911101 - Performance Indicators and Patient Experience in 7G and 10G Vacuum-assisted Excision of Probably Benign Breast Lesions N/A
Completed NCT04554316 - Aesthetic Effect of Steri-Strip Orientation on Healing and Scar Appearance in Breast Surgery N/A
Suspended NCT04151368 - Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy N/A
Recruiting NCT04605575 - Pyrotinib Plus Vinorelbine in Participants With HER2-positive Previously Treated Locally Advanced or Metastatic Breast Cancer Phase 2
Recruiting NCT05814224 - Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA N/A
Completed NCT02452333 - Oncoplastic Approach to Excisional Breast Biopsies N/A
Terminated NCT01372215 - Multi-Compression Spot Mammography N/A
Completed NCT00299039 - T3AI-Pain After Breast Surgery Phase 3
Active, not recruiting NCT05441943 - Lymphaticovenous Anastomosis as Treatment for Lymphedema N/A