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

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ClinicalTrials.gov Identifier: NCT02106598
Recruitment Status : Recruiting
First Posted : April 8, 2014
Last Update Posted : November 25, 2022
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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 Phase II study, containing a total of 67 patients with head and neck cancer. The purpose of this study is to test if imaging, with cRGDY-PEG-Cy5.5-C dots is useful for evaluating your type of cancer. This is currently not approved by the FDA. The researchers want to see if cRGDY-PEG-Cy5.5-C dots, can improve upon the usual scans. As a part of your standard of care, you will initially undergo imaging of your lymph nodes prior to your surgery. Prior to your surgery, you will be injected with a radioactive dye around the tumor site, and images will be acquired about 2 hours later using a device to image the location of the dye. We have tested, 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 your tumor 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. The particles will not treat your 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 or disease Intervention/treatment Phase
Head and Neck Melanoma Drug: fluorescent cRGDY-PEG-Cy5.5-C dots Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: N/A
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
Actual Study Start Date : April 3, 2014
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arm Intervention/treatment
Experimental: Phase 2 - Head and Neck Cancer
Patients with early oral cavity squamous cell carcinoma, and prior to standard of care wide local resection of the primary tumor and elective neck dissection, will receive a locally-administered, peritumoral injection of fluorescent cRGDY-PEG-Cy5.5-C dots (0.25 - 1 ml) around the primary lesion while under standard-of-care anesthesia for identification of optically-avid SLNs and to assess for metastatic disease. After completion of the neck dissection, nodal specimens will be examined ex vivo for fluorescence signal. Any fluorescent and non-fluorescent nodes will be compared to determine the true positive and false positive rates for cancer detection in this pilot study. No change in standard of care surgical practice will occur.
Drug: fluorescent cRGDY-PEG-Cy5.5-C dots

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 18 years of age or older
  • Histologically confirmed diagnosis of melanoma at MSKCC
  • Have one of the following disease histories:
  • Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma, oral cavity squamous cell carcinoma, and squamous cell carcinoma of the skin 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.
  • 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.

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

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Contact: Hilda Stambuk, MD 212-639-2728 stambukh@mskcc.org
Contact: Snehal Patel, MD, FRCS 212-639-3412

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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Hilda Stambuk, MD    212-639-2728      
Contact: Snehal Patel, MD, FRCS    212-639-3412      
Principal Investigator: Hilda Stambuk, MD         
Weill Cornell Medical Center Recruiting
New York, New York, United States
Contact: David Kutler, MD    646-962-4323      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Hilda Stambuk, MD Memorial Sloan Kettering Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02106598    
Other Study ID Numbers: 13-249
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: November 2022
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
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas