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Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases

This study is currently recruiting participants.
Verified May 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02106598
First Posted: April 8, 2014
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
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"). The groups are for head and neck melanoma, gynecologic, and breast cancers. As a part of the standard of care, the they will initially undergo imaging of their lymph nodes prior to their surgery. Melanoma and breast cancer 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 gynecologic 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. This particle, the size of a small protein, will be injected around sites of melanoma before or during your surgery to identify diseased nodes using a hand-held camera system. The dye-labeled particle can be viewed in tissues that may contain tumor. Based upon the clinical diagnosis, the patient may have a procedure called Reverse Lymphatic Mapping, which is a new form of sentinel lymph node mapping. The doctor will discuss this with the patient. If the patient is undergoing reverse lymphatic mapping, they will have the experimental particle injected into their hand or foot (based on their tumor type) and the standard of care injection will be injected around the tumor. This will allow the surgeon to remove only the lymph nodes that directly link to the 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 Melanoma Gynecologic Malignancies Breast Cancer Drug: fluorescent cRGDY-PEG-Cy5.5-C dots Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases

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 ]
    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: 90
Actual Study Start Date: April 3, 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1 - Breast and Gynecologic Malignancies
Participants will be investigated comprising 2 different regions of the body (breast and gynecologic malignancies). Each cohort will be analyzed separately to assess the feasibility of conducting pre-operative SLN mapping using real-time optical detection procedures and intradermal single- or double-dose injection/s of non-radioactive cRGDY-PEGCy5.5-C dots about the primary tumor site.
Drug: fluorescent cRGDY-PEG-Cy5.5-C dots
Experimental: Phase 2 - Melanoma
The first 20 participants will be enrolled and imaged at a fixed optimized dose (5 nanmoles) and volume (up to 1ml) of fluorescent cRGDY-PEGCy5.5-C dots will be locally administered about the primary tumor site, while varying the timing interval between the injection and visualization of fluorescence signal in optically-active nodes, in order to maximize detection of metastases. Fixed optimized dose, volume, and timing intervals from these studies will then be applied to another 40 enrolled participants to assess efficacy.
Drug: fluorescent cRGDY-PEG-Cy5.5-C dots

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 18 years of age or older
  • Histologically confirmed diagnosis of melanoma, breast cancer or gynecologic cancer at MSKCC
  • Have one of the following disease histories:
  • Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma or breast cancer 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 gynecologic cancer patients in whom SLN mapping and surgical excision is indicated OR
  • At the discretion of the physician or surgeon, normal baseline cardiac function based upon pre-operative evaluation
  • At the discretion of the operating surgeon, ANC>1000/mcl and platelets>100,000/mcl.
  • At the discretion of the physician or surgeon, 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, and other skin cancers in the past five years, their inclusion is up to the discretion of the physician.
  • 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
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): NCT02106598


Contacts
Contact: Wolfgang Weber, MD 212-639-7373
Contact: Snehal Patel, MD, FRCS 212-639-3412

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Wolfgang Weber, MD    646-888-3373      
Contact: Snehal Patel, MD, FRCS    212-639-3412      
Principal Investigator: Wolfgang Weber, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Wolfgang Weber, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02106598     History of Changes
Other Study ID Numbers: 13-249
First Submitted: April 3, 2014
First Posted: April 8, 2014
Last Update Posted: October 12, 2017
Last Verified: May 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
Sentinel Lymph Node Mapping
Intraoperative Sentinel
Head and Neck Melanoma
Targeted Silica Nanoparticles
cRGDY-PEG-Cy5.5-C dots
13-249

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas