A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer

June 26, 2016 updated by: So-Youn Jung, National Cancer Center, Korea

A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery

Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.

In this study, our hypothesis are as following:

  1. As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
  2. indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Indocyanine green, ICG (ICG-fluorescence)

  • ICG is the most commonly used fluorophore which approve by FDA.
  • NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
  • Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.

Nonpalpable benign brest lesion localization

  • New method for the localization and resection of non-palpable breast lesions.
  • The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.

Study Type

Interventional

Enrollment (Anticipated)

149

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • Recruiting
        • National Cancer Center
        • Contact:
        • Principal Investigator:
          • So-Youn Jung

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • nonpalpable breast tumor < 5cm in patients with breast cancer.
  • consented patients with more than 18 years
  • Eastern Cooperative Oncology Group Performance status 0 or 1
  • patients who need breast biopsy as treatment for breast cancer.

Exclusion Criteria:

  • nonpalpable breast tumor ≥ 5cm in patients with breast cancer.
  • inflammatory cancer of breast or patients who need MRM
  • pregnancy
  • history of severe allergy to ICG(Indocyanine Green)
  • iode hypersensitiveness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: indocyanine green

As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.

Intervention: Drug: indocyanine green
Drug: indocyanine green
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
Other Names:
  • Near-infrared fluorescence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection rate
Time Frame: one day
after complete resection with intraoperative ultrasound confirmed the lesion
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine the pathological stability
Time Frame: one day
determine the pathological stability with biopsy results confirmed during surgery
one day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects and availability Side effects and availability Side effects and availability side effects and availability
Time Frame: following up a week to 3 month

Itchiness, erythema, rash and other allergic reactions there could have shots later.

Itchiness, erythema, rash and other allergic reactions there could have shots later.

Itchiness, erythema, rash and other allergic reactions there could have shots later.

Itchiness, erythema, rash and other allergic reactions there could have shots later.
following up a week to 3 month
side effects and availability
Time Frame: following up a week to 3 month
After scanning, difficulty breathing, a decrease in blood pressure checked whether he had o reaction, such as anaphylactic shock.
following up a week to 3 month
side effects ans availability
Time Frame: following up a week to 3 month
The skin discoloration, verify that there aren't stay in a follow-up after three months after surgery.
following up a week to 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 26, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

June 29, 2016

Last Update Submitted That Met QC Criteria

June 26, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-1410202-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on indocyanine green

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe