Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Targeted Silica Nanoparticles for Image-Guided Intraoperative Sentinel Lymph Node Mapping in Head and Neck Melanoma, Prostate and Cervical/Uterine Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Memorial Sloan Kettering Cancer Center.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center. Identifier:
First received: April 3, 2014
Last updated: January 29, 2015
Last verified: January 2015

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 indocyanine green 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.

Condition Intervention Phase
Head and Neck Cancer
Prostate Cancer
Cervical Cancer
Uterine Cancer
Drug: fluorescent cRGDY-PEG-Cy5.5-C dots
Phase 0

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center.:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: April 2014
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,indocyanine green( ICG) 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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older
  • Histologically confirmed diagnosis of melanoma, uterine or cervical, or prostate cancer at MSKCC
  • Have one of the following disease histories:
  • Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma patients in whom SLN mapping is indicated
  • Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas
  • Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region.
  • Newly diagnosed patients with previous excisional biopsy. OR
  • Newly-diagnosed uterine or cervical cancer patients in whom SLN mapping and surgical excision is indicated OR
  • Newly-diagnosed prostate cancer with nomogram predicted risk of lymph node invasion of 2% or greater Normal baseline cardiac function based upon EKG and pre-operative evaluation
  • ANC>1000/mcl and platelets>100,000/mcl.
  • Bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).
  • For melanoma patients, If patients have a history of malignancy other than melanoma, they must be disease-free, excluding skin cancers, for ≥ 5 years at the time of enrollment.
  • All patients of childbearing and child-creating age must be using an acceptable form of birth control
  • Women who are pre-menopausal must have a negative serum pregnancy test

Exclusion Criteria:

  • Known pregnancy or breast-feeding.
  • Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the agent. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center.
Principal Investigator: Michelle Bradbury, MD, PhD Memorial Sloan Kettering Cancer Center.
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center. Identifier: NCT02106598     History of Changes
Other Study ID Numbers: 13-249
Study First Received: April 3, 2014
Last Updated: January 29, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan Kettering Cancer Center.:
Sentinel Lymph Node Mapping
Intraoperative Sentinel
Head and Neck
Targeted Silica Nanoparticles
cRGDY-PEG-Cy5.5-C dots

Additional relevant MeSH terms:
Head and Neck Neoplasms
Prostatic Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female
Genital Neoplasms, Male
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Prostatic Diseases
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases processed this record on February 25, 2015