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Trial Title:
Targeted Silica Nanoparticles for Real-Time Image-Guided Intraoperative Mapping of Nodal Metastases
NCT ID:
NCT02106598
Condition:
Head and Neck Melanoma
Conditions: Official terms:
Melanoma
Conditions: Keywords:
Sentinel Lymph Node Mapping
Intraoperative Sentinel
Head and Neck Melanoma
Targeted Silica Nanoparticles
cRGDY-PEG-Cy5.5-C dots
13-249
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
fluorescent cRGDY-PEG-Cy5.5-C dots
Arm group label:
Phase 2 - Head and Neck Cancer
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Weill Cornell Medical Center
Address:
City:
New York
Country:
United States
Start date:
April 3, 2014
Completion date:
April 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02106598
http://www.mskcc.org/