RECRUITING

Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery

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/II trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.

Official Title

A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Lung Cancer During Surgical Procedures

Quick Facts

Study Start:2018-07-19
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03582124

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. * Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven
  2. * Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and/or curative intent for lung cancer
  3. * Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 0-2
  4. * Hemoglobin ≥ 9 gm/dL
  5. * White blood cell count \> 3000/mm\^3
  6. * Platelet count ≥ 100,000/mm\^3
  7. * Serum creatinine ≤ 1.5 times upper reference range
  1. * Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
  2. * Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
  3. * History of infusion reactions to monoclonal antibody therapies
  4. * Pregnant or breastfeeding
  5. * Magnesium or potassium lower than the normal institutional values
  6. * Subjects receiving class IA (quinidine, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  7. * Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
  8. * Prisoners, institutionalized individuals, and patients unable to consent for themselves

Contacts and Locations

Study Contact

Roan C Raymundo
CONTACT
650-721-4071
rcraymun@stanford.edu

Principal Investigator

Natalie Lui
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University, School of Medicine
Palo Alto, California, 94304
United States

Collaborators and Investigators

Sponsor: Eben Rosenthal

  • Natalie Lui, PRINCIPAL_INVESTIGATOR, Stanford University

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 Date2018-07-19
Study Completion Date2027-02

Study Record Updates

Study Start Date2018-07-19
Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Carcinoma
  • Metastatic Malignant Neoplasm in the Lung
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8