Actively Recruiting

Phase 1
Age: 19Years +
All Genders
NCT05945875

Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer

Led by Vanderbilt-Ingram Cancer Center · Updated on 2025-10-03

40

Participants Needed

1

Research Sites

273 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt-Ingram Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon emission computed tomography (SPECT)/computed tomography (CT) and panitumumab-IRDye800 fluorescence imaging during surgery (intraoperative), to detect disease in patients with head and neck cancer. 111In-panitumumab is an imaging agent made of a monoclonal antibody that has been labeled with a radioactive molecule called indium In 111. The agent targets and binds to receptors on tumor cells. This allows the cells to be visualized and assessed with SPECT/CT imaging techniques. SPECT is special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. CT is an imaging technique for examining structures within the body by scanning them with x-rays and using a computer to construct a series of cross-sectional scans along a single axis. Panitumumab-IRDye800 is an imaging agent composed of panitumumab, a monoclonal antibody, linked to a fluorescent dye called IRDye800. Upon administration, panitumumab-IRDye800 targets and binds to receptors on tumor cells. This allows the tumor cells to be detected using fluorescence imaging during surgery. Adding 111In-panitumumab SPECT/CT imaging to intraoperative panitumumab-IRDye800 fluorescence imaging may be more effective at detecting disease in patients with head and neck cancer.

CONDITIONS

Official Title

Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 19 years or older
  • Biopsy-confirmed squamous cell carcinoma of the head and neck
  • Any T stage and subsite within the head and neck
  • Scheduled for surgical resection and neck dissection
  • Includes recurrent disease or new primary tumors
  • Planned elective neck dissection for clinical node-negative or node-positive disease
  • Clinical node-positive disease defined as metastasis in a single, ipsilateral lymph node 3 cm or less
  • Hemoglobin level 9 gm/dL or higher
  • White blood cell count greater than 3000/mm^3
  • Platelet count 100,000/mm^3 or higher
  • Serum creatinine no greater than 1.5 times upper reference range
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Myocardial infarction, cerebrovascular accident, uncontrolled congestive heart failure, significant liver disease, or unstable angina within 6 months prior to enrollment
  • QT prolongation on pretreatment ECG (greater than 440 ms in males or 450 ms in females)
  • History of infusion reactions to monoclonal antibody therapies
  • History of allergies to iodine
  • Pregnant or breastfeeding
  • Magnesium or potassium below normal institutional values
  • Use of class IA or class III antiarrhythmic agents
  • History or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Severe renal disease or anuria
  • Thyroid stimulating hormone greater than 13 micro international units/mL

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37203

Actively Recruiting

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Research Team

N

Nicole Jones

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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