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

Primary Purpose

Head and Neck Melanoma

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

fluorescent cRGDY-PEG-Cy5.5-C dots

About this trial

This is an interventional diagnostic trial for Head and Neck Melanoma focused on measuring Sentinel Lymph Node Mapping, Intraoperative Sentinel, Head and Neck Melanoma, Targeted Silica Nanoparticles, cRGDY-PEG-Cy5.5-C dots, 13-249

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Memorial Sloan Kettering Cancer Center
Weill Cornell Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase 2 - Head and Neck Cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

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-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

Secondary Outcome Measures

Full Information

NCT ID

NCT02106598

First Posted

April 3, 2014

Last Updated

September 7, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02106598

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 3, 2014 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Melanoma

Keywords

Sentinel Lymph Node Mapping, Intraoperative Sentinel, Head and Neck Melanoma, Targeted Silica Nanoparticles, cRGDY-PEG-Cy5.5-C dots, 13-249

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 2 - Head and Neck Cancer

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

fluorescent cRGDY-PEG-Cy5.5-C dots

Primary Outcome Measure Information:

Title

feasibility of conducting pre-operative SLN mapping

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hilda Stambuk, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Weill Cornell Medical Center

City

New York

State/Province

New York

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33734415

Citation

Zanoni DK, Stambuk HE, Madajewski B, Montero PH, Matsuura D, Busam KJ, Ma K, Turker MZ, Sequeira S, Gonen M, Zanzonico P, Wiesner U, Bradbury MS, Patel SG. Use of Ultrasmall Core-Shell Fluorescent Silica Nanoparticles for Image-Guided Sentinel Lymph Node Biopsy in Head and Neck Melanoma: A Nonrandomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e211936. doi: 10.1001/jamanetworkopen.2021.1936.

Results Reference

derived

Links:

URL

http://www.mskcc.org/

Description

Memorial Sloan Kettering Cancer Center

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

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