Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/29/2018 |
| Start Date: | December 28, 2017 |
| End Date: | November 2019 |
| Contact: | Stephen Grobmyer, MD |
| Email: | CancerCenterResearch@ccf.org |
| Phone: | 866-223-8100 |
Evaluation of an Integrated Imaging System (Smartgoggles) For In Vivo Detection of Fluorescently Labeled Lesions: A Pilot Study To Visualize Sentinel Lymph Nodes After Peritumoral Injection of Indocyanine Green
This is a pilot study to test and characterize the ability of the SmartGoggles system to
detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test
the sensitivity and specificity of the SmartGoggles to detect indocyanine green (ICG)
accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of
ICG (Cardio-GreenTM), under standard-of-care application conditions.
detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test
the sensitivity and specificity of the SmartGoggles to detect indocyanine green (ICG)
accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of
ICG (Cardio-GreenTM), under standard-of-care application conditions.
Primary Objective -Positive fluorescence signal in SLNs imaged by the SmartGoggles system.
Secondary Objectives
- Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.
- Comparison of lesions detected by the SmartGoggles vs. lesions detected using SPY Elite
vs. gold standard of gamma probe and blue dyes.
Exploratory Objectives
-Collection of preliminary data for a future, powered study for lymphatic mapping in breast
cancer
Study Design This is an unpowered pilot study to determine the sensitivity of the new
SmartGoggles device, for detection of ICG fluorescence in SLNs of breast cancers in a
clinical setting. The investigators have chosen to examine ICG as the contrast agent and
breast cancer as the clinical target, because this agent is FDA-approved and is regularly
used for lymphatic mapping (skin cancers). The study team will be applying ICG for the same
length of time as the standard-of-care procedures including radiotracers and blue dyes. The
study involves a single visit, lasting ~3-4 hours total. Multiple biopsies will be performed
if multiple SLNs are identified. The study will enroll 6 patients, and then be suspended for
an interim analysis. If it is determined that more data are needed to reliably determine the
endpoints, then 4 additional patients will be recruited, for a total of 10 patents.
Secondary Objectives
- Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.
- Comparison of lesions detected by the SmartGoggles vs. lesions detected using SPY Elite
vs. gold standard of gamma probe and blue dyes.
Exploratory Objectives
-Collection of preliminary data for a future, powered study for lymphatic mapping in breast
cancer
Study Design This is an unpowered pilot study to determine the sensitivity of the new
SmartGoggles device, for detection of ICG fluorescence in SLNs of breast cancers in a
clinical setting. The investigators have chosen to examine ICG as the contrast agent and
breast cancer as the clinical target, because this agent is FDA-approved and is regularly
used for lymphatic mapping (skin cancers). The study team will be applying ICG for the same
length of time as the standard-of-care procedures including radiotracers and blue dyes. The
study involves a single visit, lasting ~3-4 hours total. Multiple biopsies will be performed
if multiple SLNs are identified. The study will enroll 6 patients, and then be suspended for
an interim analysis. If it is determined that more data are needed to reliably determine the
endpoints, then 4 additional patients will be recruited, for a total of 10 patents.
Inclusion Criteria:
- Subjects with at least 1 lesion of tumor of the breast
- Subjects must have the ability to understand and the willingness to sign a written
informed consent document.
Exclusion Criteria:
- Subjects who have been treated with radiation therapy on the chest.
- Has had previous sentinel lymph node biopsy
- Has a known hypersensitivity to ICG, methylene blue and 99mTc-colloid.
We found this trial at
1
site
Cleveland, Ohio 44195
Principal Investigator: Stephen Grobmyer, MD
Phone: 866-223-8100
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