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Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Head and Neck Cancers: a Window of Opportunity Study
This research study is studying the effect of different drugs as possible treatments for salivary and other head and neck cancers/ The name of the study intervention involved in this study is: \-- implantable microdevice
This window-of-opportunity pilot study will assess the safety and feasibility of using an implantable microdevice (IMD) to efficiently measure local intratumor response to multiple drugs within previously untreated head and neck cancer patients undergoing definitive oncologic resection. * This research study is a Pilot Study, which is the first-time investigators are examining this study device in salivary and head and neck cancers. The placement and removal of the microdevice is being tested for the first time in this type of cancer. * This research study involves drugs that are released by a small implantable microdevice (IMD) as small as the tip of a needle, that is inserted into the tumor and is then removed 3-5 days later during surgery. * The microdevice can hold up to 20 drugs alone or in combinations in very small concentrations that are able to access the cancer through small pores in the device. When the device is removed along with the cancer at the time of surgery, it will be evaluated to understand which drug(s) may be effective to treat these cancers. It is expected that about 30 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has not approved the microdevice a treatment for any disease. AACRF, a research foundation, is supporting this research study by providing funding for the research study, the study drugs and study procedures.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Start Date
November 1, 2023
Primary Completion Date
April 1, 2029
Completion Date
August 1, 2029
Last Updated
January 26, 2026
30
ESTIMATED participants
Implantable Microdevice (IMD)
COMBINATION_PRODUCT
Lead Sponsor
Brigham and Women's Hospital
Collaborators
NCT05884320
NCT04704661
Data Source & Attribution
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