SUSPENDED

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

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Head and Neck Cancer

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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

The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell Carcinoma. The secondary objective is to compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to Day of Surgery versus conventional local injection with an optical dye at the time of surgery.

Official Title

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

Quick Facts

Study Start:2021-03-30
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT04840472

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. * Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
  2. * Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
  3. * Planned standard of care elective neck dissection for a cN0 or cN1 disease. Clinical N1 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.
  4. * Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
  5. * Hemoglobin ≥ 9 gm/dL
  6. * White blood cell count \> 3000/mm3
  7. * Platelet count ≥ 100,000/mm3
  8. * Serum creatinine ≤ 1.5 times upper reference range
  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. * History of infusion reactions to monoclonal antibody therapies.
  3. * Pregnant or breastfeeding.
  4. * Magnesium or potassium lower than the normal institutional values.
  5. * Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
  6. * Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
  7. * Severe renal disease or anuria.

Contacts and Locations

Principal Investigator

Fred Baik, MD
PRINCIPAL_INVESTIGATOR
Stanford Universiy

Study Locations (Sites)

Stanford University
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Fred Baik, MD, PRINCIPAL_INVESTIGATOR, Stanford Universiy

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 Date2021-03-30
Study Completion Date2027-03

Study Record Updates

Study Start Date2021-03-30
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Cancer