NCT05553782 Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers
| NCT ID | NCT05553782 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Salivary Gland Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-11-01 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion 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 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. Exclusion Criteria: * 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
Contact & Investigator
Glenn J. Hanna, M.D
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT05553782 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Salivary Gland Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05553782 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05553782 currently recruiting?
Yes, NCT05553782 is actively recruiting participants. Contact the research team at glenn_hanna@dfci.harvard.edu for enrollment information.
Where is the NCT05553782 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States.
Who is sponsoring the NCT05553782 clinical trial?
NCT05553782 is sponsored by Brigham and Women's Hospital. The principal investigator is Glenn J. Hanna, M.D at Dana-Farber Cancer Institute. The trial plans to enroll 30 participants.
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