Recruiting
Early Phase 1

Implantable Microdevice

Sponsor:

Brigham and Women's Hospital

Code:

NCT05553782

Conditions

Salivary Gland Cancer

Adenoid Cystic Carcinoma of the Salivary Gland

Squamous Cell Carcinoma of Head and Neck

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Implantable Microdevice (IMD)

Study Details

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

Conditions

Salivary Gland Cancer

Adenoid Cystic Carcinoma of the Salivary Gland

Squamous Cell Carcinoma of Head and Neck

Head and Neck Cancer

Study ID

NCT05553782

Start date

Nov 1, 2023

Status verified date

Jan, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Apr 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IMD PLACEMENT + SURGICAL RESECTION + ADJUVANT TREATMENT ARM

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

Interventions

Implantable Microdevice (IMD)

  • Percutaneous CT image-guided placement of the microdevice(s). At least one, and up to 3, devices will be placed in each tumor.
  • Drugs will be released from the microdevice into local tumor tissues. The duration of drug release will be for a period of 3-5 days while the microdevice is in the tumor prior to retrieval. The local tissue is retrieved along with the microdevice and no residual drug will remain.
  • Each microdevice harbors up to 20 drugs and/or drug combinations relevant to the treatment of head and neck cancer. The drugs used will include some standard agents approved by the Food and Drug Administration (FDA) for treatment of different types of cancers, or drugs classes under investigational.
  • Drugs may include all or a subset of the following which each may be tested as single agents or in any number of combinations including, but not limited to: Lenvatinib, Axitinib, All trans retinoic acid (ATRA), Venetoclax, Pembrolizumab, Cisplatin, Carboplatin, Vinorelbine

Primary outcome measure

  • Grade 3 or Higher Treatment-Related Toxicity Rate [ Time Frame: AE assessed on post-operative visit, which take placed between 7-14 days after the surgical procedure. ]

Central Contacts and Locations

Central contacts

Glenn J. Hanna, M.D.

(617) 632-3090glenn_hanna@dfci.harvard.edu

Oliver Jonas, Ph.D.

OJONAS@BWH.HARVARD.EDU

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Glenn J Hanna, MD

617-632-3090glenn_hanna@dfci.harvard.edu

Principal Investigator:

Glenn J Hanna, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Glenn Hanna, MD

617-632-3090gjhanna@partners.org

Principal Investigator:

Glenn Hanna, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • Salivary Gland Cancer
  • Adenoid Cystic Carcinoma of the Salivary Gland
  • Implantable Microdevice IMD
  • Squamous Cell Carcinoma of Head and Neck

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-01-26.