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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site contact updatedv6
  2. Minor Site contact updatedv5
  3. Minor Start date changed from estimate of Nov 30, 2023 to Oct 3, 2023v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  5. Notable Start date: Aug 15, 2023 to Nov 30, 2023 Primary completion date: Oct 31, 2027 to Dec 31, 2027 · Completion date: Oct 31, 2028 to Dec 31, 2028v2 Show 2 more changesShow less
    • Primary completion date: Oct 31, 2027 to Dec 31, 2027
    • Completion date: Oct 31, 2028 to Dec 31, 2028
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05945875
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov