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New treatment option for Salivary Gland Cancer
Official title Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers
ClinicalTrials.gov ID: NCT05553782
What this study is testing
What is Implantable Microdevice (IMD)?
Implantable Microdevice (IMD) is an investigational medicine, being studied as a potential treatment for salivary gland cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically confirmed head and neck cancer (salivary or ACC type, or squamous cell carcinoma) without evidence of...
- 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...
- Participants will undergo laboratory testing within 7 days prior to the microdevice placement: they are required to have a platelet count...
You likely can't join if
- 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...
- Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the device placement and...
- Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures. If the patient is on...
See the full eligibility criteria
- 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...
- 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...
- 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 people 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.