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Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions

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ClinicalTrials.gov Identifier: NCT02802553
Recruitment Status : Not yet recruiting
First Posted : June 16, 2016
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: SmartGoggle Other: Cardio-Green Device: SPY Elite Device: gamma probe Other: Blue Dyes Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Integrated Imaging Goggles
Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by SPY Elite in addition to those detected by gamma probe and blue dyes.
Device: SmartGoggle
SmartGoggle is a novel stereoscopic wearable multimodal intraoperative imaging and display systems entitled Integrated Imaging Goggles for assessment of SLNs. The prototype system offers real time stereoscopic fluorescence imaging along with in vivo handheld microscopy. The investigators have found that the system can detect fluorescent targets with as low as 1.2 picomoles ICG (60 nM concentration). The hand-held microscopy module has a resolution of 25 micron. The prototype system has 2 complementary metal-oxide-semiconductor (CMOS) imaging sensors housed on a printed circuit board (PCB) with imaging lenses and emission filters optimized for ICG dye. The light source provides concurrent excitation centered at 780 nm and white light illumination with OD6 level cut-off. The SmartGoggles is a non-invasive imaging system that does not require contact with patients.
Other Name: Integrated Imaging Goggles

Other: Cardio-Green
Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. Indocyanine Green for Injection USP is dissolved using Sterile Water for Injection, and is to be administered intravenously.
Other Name: Indocyanine Green

Device: SPY Elite
Previously validated fluorescence detection system. Will be used to look at the same regions as the SmartGoggles to confirm sensitivity

Device: gamma probe
Gold standard for fluorescence detection. The gamma probe and blue dyes will be used in conjunction to confirm presence of Sentinel Lymph Nodes (SLNs). The gamma probe provides non-imaging sensing data and the blue dyes provide visual signs for detection of SLNs.

Other: Blue Dyes
Gold standard for fluorescence detection. The gamma probe and blue dyes will be used in conjunction to confirm presence of Sentinel Lymph Nodes (SLNs). The gamma probe provides non-imaging sensing data and the blue dyes provide visual signs for detection of SLNs.




Primary Outcome Measures :
  1. binary response of the number of patients in which the SmartGoggles identifies the same Sentinel Lymph Nodes (SLN) within each patient as those identified by the gamma probe and blue dyes gold standard. [ Time Frame: At the end of the procedure, about 50 minutes ]
    Agreement on 6 consecutive patients would occur less than 2% of the time by random chance (p = 0.56 = 0.016). If the two methods agree on all 6 patients, the current protocol will end successfully. However, if the two methods fail to agree on the SLN once among the first 6 patients, enrollment will continue to 10 patients or until a second failed agreement occurs.


Secondary Outcome Measures :
  1. binary response of the number of patients in which the SmartGoggles identifies the same Sentinel Lymph Nodes (SLN) within each patient as those identified by the SPY Elite imaging system. [ Time Frame: At the end of the procedure, about 50 minutes ]
    A commercial imaging system that measures fluorescence output of ICG will be used to measure the near infrared fluorescence in vivo. Measurements are painless and involve no risk to the patient. The measurements are non-contact and recorded by a computer; each measurement is painless and takes 10 seconds. The signal is calibrated against known fluorescence standards, and the relative amount of ICG in a given measurement is interpolated from the standard curve.

  2. Number of samples with ICG detected in biopsy tissue [ Time Frame: At the end of the procedure, about 50 minutes ]
    Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.

  3. Number of samples with lymph node detected in biopsy tissue [ Time Frame: At the end of the procedure, about 50 minutes ]
    Confirmation of lymph node tissue within lesions per histologic tissue exam by SLN biopsy.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802553


Contacts
Contact: Stephen Grobmyer, MD 866-223-8100 CancerCenterResearch@ccf.org

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Not yet recruiting
Cleveland, Ohio, United States, 44195
Contact: Stephen Grobmyer, MD    866-223-8100    CancerCenterResearch@ccf.org   
Principal Investigator: Stephen Grobmyer, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Stephen Grobmyer, MD Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02802553     History of Changes
Other Study ID Numbers: CASE4116
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Case Comprehensive Cancer Center:
SmartGoggles
sentinel lymph nodes
indocyanine green
Cardio-Green
Spy Elite