Clinical trial · Interventional
Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers
Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Head and Neck Cancers: a Window of Opportunity Study
NCT05553782CI-TRIAL-00101608recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoid Cystic Carcinoma of the Salivary Gland | Salivary Gland Adenoid Cystic Carcinoma | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Salivary Gland Cancer | Malignant Salivary Gland Neoplasm | ALIAS | 0.90 |
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Implantable Microdevice (IMD) | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMD PLACEMENT + SURGICAL RESECTION + ADJUVANT TREATMENT ARM
- description
- Newly diagnosed, localized head and neck cancers undergoing surgical resection * Interventional radiology guided IMD placement * Planned oncologic resection with IMD retrieval 3-5 days after placement * Standard of care adjuvant treatment * Tumor specimen analysis for local drug response and molecular analysis
- interventionNames
- Combination Product: Implantable Microdevice (IMD)
Primary outcomes (1)
- measure
- Grade 3 or Higher Treatment-Related Toxicity Rate
- timeFrame
- AE assessed on post-operative visit, which take placed between 7-14 days after the surgical procedure.
- description
- 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.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.