Targeted Silica Nanoparticles for Image-Guided Intraoperative Sentinel Lymph Node Mapping in Head and Neck Melanoma, Prostate and Cervical/Uterine Cancer Patients
Current imaging devices usually detect cancer prior to surgery. However, these devices cannot be used during the surgical procedure to visualize lymph nodes with cancer (called "sentinel lymph nodes"). This is a pilot study, containing a total of 30 patients. There will be 10 patients from each of three groups. The groups are for head and neck melanoma, cervical/uterine, and prostate cancers. As a part of the standard of care, the they will initially undergo imaging of their lymph nodes prior to their surgery. Melanoma patients will be injected with a radioactive dye around the tumor site, and images will be acquired about 2 hours the location of the later using a device to image the dye. For cervical or uterine cancer patients, they will be injected with a blue dye in the operating room and then images will be acquired soon after. In addition, the investigators will test, for the first time in humans, a new, experimental dye-labeled particle (dots), cRGDY-PEG-Cy5.5-C dots for lymph node mapping. For prostate cancer patients, this is the only injection they will receive. This particle, the size of a small protein, will be injected around sites of melanoma in the operating room to identify diseased nodes using a hand-held camera system. The dye-labeled particle can be viewed in tissues that may contain tumor. The particles will not treat the cancer and any images or information found during this study will not be used for your treatment. The information collected may be used to guide the design of future studies to detect and/or treat tumors.
Head and Neck Cancer
Drug: fluorescent cRGDY-PEG-Cy5.5-C dots
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Targeted Silica Nanoparticles for Image-Guided Intraoperative Sentinel Lymph Node Mapping in Head and Neck Melanoma, Prostate and Cervical/Uterine Cancer Patients|
- feasibility of conducting pre-operative SLN mapping [ Time Frame: 1 year ] [ Designated as safety issue: No ]using real-time optical detection procedures and intradermal single- or double-dose injection/s of non-radioactive cRGDY-PEG-Cy5.5-C dots about the primary tumor site. Feasibility will be determined on the basis of achieving adequate image contrast for detection, as defined by signal-to-background ratios, and whether optical signal distinguishes diseased SLNs from non-diseased ones
|Study Start Date:||April 2014|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Head & Neck Melanoma, Prostate, Uterine & Cervical Patients
In melanoma patients, pre-operatively, the patient will initially undergo routine imaging 0.5 - 2 hrs after local injection of 99mTc-technetium sulfur colloid per the standard procedure. In the operative suite, intradermal, 4-quadrant injections of cRGDY-PEG-Cy5.5-C dots will be administered as a single or multiple doses about the tumor site.
In uterine and cervical patients, blue dye will be injected in the OR suite at the same time as the C dots. In prostate cancer patients, only cRGDY-PEG-Cy5.5-C dots will be administered in the operating suite as a single or multiple doses about the tumor site.
The patient's optical scans will be acquired in the surgical suite using the ArtemisTM portable fluorescence camera system (f 2.4; 15 frames per second; resolution 50 um) and video monitoring. In the operating room, vital signs will be monitored per routine prior to and after agent administration.
|Drug: fluorescent cRGDY-PEG-Cy5.5-C dots|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02106598
|Contact: Michelle Bradbury, MD, Phd||646-888-3373|
|Contact: Snehal Patel, MD||212-639-3412|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Michelle Bradbury, MD, PhD 646-888-3373|
|Contact: Snehal Patel, MD 212-639-3412|
|Principal Investigator: Michelle Bradbury, MD, PhD|
|Principal Investigator:||Michelle Bradbury, MD, PhD||Memorial Sloan-Kettering Cancer Center|