Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT05901545
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Panitumumab — BIOLOGICAL
    Given by IV
  • Indium In 111 Panitumumab — OTHER
    Given by IV
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT/CT
  • Computed Tomography — PROCEDURE
    Undergo SPECT/CT
  • Surgical Procedure — PROCEDURE
    Undergo standard of care surgery
  • Imaging agent — OTHER
    Receive local injection of optical dye
  • Intraoperative Imaging — PROCEDURE
    Undergo Intraoperative Imaging
  • Near Infrared Imaging — PROCEDURE
    Undergo Near Infrared Imaging
  • Electrocardiography — PROCEDURE
    Undergo Electrocardiography
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography/computed tomography (SPECT/CT). SPECT/CT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.

Key Dates

Start date
Aug 22, 2023
Status verified
Feb 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
    Patients receive loading dose of panitumumab IV over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.

Primary Outcome Measure

Incidence of adverse events grade 2 or higher [ Time Frame: Up to 15 days after administration of study drug ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232
Vanderbilt-Ingram Service Services for Timely Access
[email protected]
800-811-8480
Eben Rosenthal, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Vanderbilt University/Ingram Cancer Center· Nashville, TN

Related Studies