RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Official Title Targeted Dual Modality Imaging (TDMI) for Detection and Removal of Head and Neck Cancer

Quick Facts

Study Start:2023-10-03
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05945875

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 19 years
  2. * Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
  3. * Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed
  4. * Planned standard of care elective neck dissection for a cN0 or node- positive disease. Clinical node- positive disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging
  5. * Hemoglobin \>= 9 gm/dL
  6. * White blood cell count \> 3000/mm\^3
  7. * Platelet count \>= 100,000/mm\^3
  8. * Serum creatinine =\< 1.5 times upper reference range
  9. * Ability to understand and the willingness to sign a written informed consent document
  1. * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
  2. * Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
  3. * History of infusion reactions to monoclonal antibody therapies
  4. * History of allergies to iodine
  5. * Pregnant or breastfeeding
  6. * Magnesium or potassium lower than the normal institutional values
  7. * Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  8. * Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  9. * Severe renal disease or anuria
  10. * Thyroid stimulating hormone (TSH) \> 13 micro international units/mL

Contacts and Locations

Study Contact

Vanderbilt-Ingram Services for Timely Access
CONTACT
800-811-8480
cip@vumc.org

Principal Investigator

Eben Rosenthal, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center

Study Locations (Sites)

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Vanderbilt-Ingram Cancer Center

  • Eben Rosenthal, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University/Ingram Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-03
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-10-03
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Squamous Cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma