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Drug Screening Using Implantable Microdevice for Salivary and Head and Neck Cancers

This study is testing a new way to screen different drugs for salivary gland cancer and other head and neck cancers. Researchers are using a small Implantable Microdevice (IMD) that is placed directly into your tumor for 3-5 days. This device releases tiny amounts of different drugs into the tumor. When the tumor is removed during surgery, doctors will check which drugs might be most effective. This is a pilot study, meaning it's the first time this device is being used in this type of cancer. The main goal is to see if the device is safe and how well it works. About 30 people are expected to join this study. The microdevice is not yet approved by the FDA as a treatment.

Study design
This is a pilot study, which is the first time this device is being tested in salivary and head and neck cancers. About 30 participants will be enrolled.
What's involved
You would have an Implantable Microdevice (IMD) placed into your tumor, which will stay there for 3-5 days. It will then be removed during your planned surgery.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be checked at a post-operative visit, which takes place between 7-14 days after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05553782

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Brigham and Women's Hospital
~30 participants
Updated 2026-01-26 on ClinicalTrials.gov
What's tested:Implantable Microdevice (IMD)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Grade 3 or Higher Treatment-Related Toxicity Rate
Measured over AE assessed on post-operative visit, which take placed between 7-14 days after the surgical procedure.

Conditions

Salivary Gland Cancer
Adenoid Cystic Carcinoma of the Salivary Gland
Squamous Cell Carcinoma of Head and Neck
Head and Neck Cancer

Explore related trials

Adenoid Cystic CarcinomaHead and Neck Squamous Cell CarcinomaMalignant Head and Neck Neoplasm

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Glenn J. Hanna, M.D · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Glenn J. Hanna, M.D.
[email protected]
(617) 632-3090
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

Participants who are receiving any other investigational agents.
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.
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.
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

What this trial measures

  • Grade 3 or Higher Treatment-Related Toxicity RateAE assessed on post-operative visit, which take placed between 7-14 days after the surgical procedure.

    All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.