Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers

Korábbi kezelés

• Participants who are receiving any other investigational agents.
• Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the device placement and the potential risk to the pregnancy of the surgery/device placement.

Más betegség

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
• Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures. If the patient is on systemic anticoagulation, this should be discussed with the overall PI and treating surgeon

• Participants must have histologically confirmed head and neck cancer (salivary or ACC type, or squamous cell carcinoma) without evidence of recurrent, metastatic or advanced, incurable disease undergoing definitive surgical management; any stage disease is permitted (American Joint Committee on Cancer 2017 8th edition).
• Age 18 years or older.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• A measurable primary tumor site both clinically and radiologically measuring at least 1 x 1 cm.
  • Patients must be deemed medically fit to undergo both percutaneous and surgical procedures by their treating head and neck surgeon and medical oncologist.
• Participants will undergo laboratory testing within 7 days prior to the microdevice placement: they are required to have a platelet count ≥50,000/mcL, PT/INR <2, and aPTT <1.5x upper limit of normal.
• Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days
• Ability to understand and the willingness to sign a written informed consent document.