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Intraoperative Imaging of Breast Cancer With Indocyanine Green (ICG)

Primary Purpose

Invasive Ductal Carcinoma, Invasive Lobular Carcinoma, Ductal Carcinoma

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Invasive Ductal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients over 18 years of age
  2. Women with newly diagnosed, operable invasive ductal carcinoma, invasive lobular carcinoma or ductal carcinoma who are deemed breast conservation surgery candidates (i.e. lumpectomy +/- sentinel node biopsy).
  3. Breast cancer needs to be unifocal as determined by clinical parameters, e.g. by palpation or by breast imaging findings including mammogram, US and/or breast MRI. Multifocal disease, i.e. cancer confined to one quadrant, is eligible if patients are deemed breast conservation candidates.
  4. Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

  1. Newly diagnosed breast cancer patients who are not breast conservation candidates and those with multicentric breast cancer (breast cancer documented in multiple quadrants by breast imaging or exam)
  2. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
  3. Subjects with a history of iodide allergies

  4. At-risk patient populations

    1. Homeless patients
    2. Patients with drug or alcohol dependence
    3. Patients unable to participate in the consent process

Sites / Locations

  • Hospital of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IV Injection of ICG

Arm Description

Outcomes

Primary Outcome Measures

Identification
The primary outcome will be the proportion of patient's tumors identified by ICG uptake versus the proportion of patients identified by visual and tactile methods by the surgeon (considered standard of care)

Secondary Outcome Measures

Evaluation
a) Correlate detected ICG excitation in shave lumpectomy margins with quantity of residual disease in histologic sections.
Evaluation
b) evaluate the rate of re-excision in participants compared to a matched case- control cohort with similar clinicopathological characteristics undergoing breast conservation surgery.
Evaluation
C) evaluate progression free survival in our study cohorts

Full Information

First Posted
January 18, 2013
Last Updated
January 26, 2021
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01796041
Brief Title
Intraoperative Imaging of Breast Cancer With Indocyanine Green
Acronym
ICG
Official Title
A Phase 0/1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subject Undergoing Breast Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 9, 2016 (Actual)
Study Completion Date
November 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
According to the World Health Organization, breast cancer is the most common cancer in women, and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000 women perished from the disease in 2002. Surgery remains the best option for patients presenting with operable Stage I, II or III cancers. Breast conservation surgery has been shown to be as efficacious as mastectomy. About 60-70% of these women with operable breast cancer are breast conservation candidates. However, the need to achieve negative tumor margins often requires a second operation (re-excision) in up to 70% of the women having lumpectomy surgery. Currently, tumor margins assessment in the operating room is often assessed grossly by palpation. The ability to evaluate tumor margin using our proposed intraoperative imaging technique may provide the surgeon with an alternative, and hopefully, more sensitive method to assess tumor margins which may decrease re-excision and the morbidity associated with additional surgery, and, perhaps, lower the risk of local regional recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Ductal Carcinoma, Invasive Lobular Carcinoma, Ductal Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV Injection of ICG
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
ICG, The chemical formula is C45H47N2O6S2Na
Primary Outcome Measure Information:
Title
Identification
Description
The primary outcome will be the proportion of patient's tumors identified by ICG uptake versus the proportion of patients identified by visual and tactile methods by the surgeon (considered standard of care)
Time Frame
After infusion of ICG
Secondary Outcome Measure Information:
Title
Evaluation
Description
a) Correlate detected ICG excitation in shave lumpectomy margins with quantity of residual disease in histologic sections.
Time Frame
0-5 years after surgery
Title
Evaluation
Description
b) evaluate the rate of re-excision in participants compared to a matched case- control cohort with similar clinicopathological characteristics undergoing breast conservation surgery.
Time Frame
0-5 years after surgery
Title
Evaluation
Description
C) evaluate progression free survival in our study cohorts
Time Frame
0-5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients over 18 years of age Women with newly diagnosed, operable invasive ductal carcinoma, invasive lobular carcinoma or ductal carcinoma who are deemed breast conservation surgery candidates (i.e. lumpectomy +/- sentinel node biopsy). Breast cancer needs to be unifocal as determined by clinical parameters, e.g. by palpation or by breast imaging findings including mammogram, US and/or breast MRI. Multifocal disease, i.e. cancer confined to one quadrant, is eligible if patients are deemed breast conservation candidates. Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria: Newly diagnosed breast cancer patients who are not breast conservation candidates and those with multicentric breast cancer (breast cancer documented in multiple quadrants by breast imaging or exam) Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery Subjects with a history of iodide allergies At-risk patient populations Homeless patients Patients with drug or alcohol dependence Patients unable to participate in the consent process
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Intraoperative Imaging of Breast Cancer With Indocyanine Green

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