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

Status:	Recruiting
Conditions:	Breast Cancer, Prostate Cancer, Colorectal Cancer, Skin Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Women's Studies
Therapuetic Areas:	Oncology, Reproductive
Healthy:	No
Age Range:	18 - Any
Updated:	4/5/2019
Start Date:	April 3, 2014
End Date:	April 2020
Contact:	Hilda Stambuk, MD
Email:	stambukh@mskcc.org
Phone:	212-639-2728

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 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.
For breast cancer patients the purpose of this study is to test if cRGDY-PEG-Cy5.5-C dots
that can be used to take pictures of breast cancer. As a part of the standard of care, the
patient will initially undergo imaging of the lymph nodes prior to surgery. Prior to your
surgery, you will be injected with a radioactive dye around the tumor site, and images will
be acquired. Physicians 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 the umor before or during
surgery to identify nodes using a hand-held camera system. The dye-labeled particle can be
viewed in tissues that may contain tumor.

Inclusion Criteria:

- 18 years of age or older

- Histologically confirmed diagnosis of melanoma, breast cancer or colorectal 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 colorectal cancer patients in whom SLN mapping and total mesorectal
excision with lateral pelvic sidewall dissection is indicated

- 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.

We found this trial at

sites

Weill Cornell Medical Center

New York, New York 10065

Phone: 646-962-4323

from

New York, NY