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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv8
  2. Site contact updatedv7
  3. Eligibility criteria shortened, about 9 words Site contact updatedv6 Show 1 more changeShow less
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  4. Start date changed from estimate of Apr 30, 2024 to Aug 22, 2023v5
  5. Start date: Dec 31, 2023 to Apr 30, 2024 Primary completion date: Aug 30, 2028 to Nov 30, 2028 · Completion date: Aug 30, 2029 to Nov 30, 2029v4 Show 2 more changesShow less
    • Primary completion date: Aug 30, 2028 to Nov 30, 2028
    • Completion date: Aug 30, 2029 to Nov 30, 2029
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Sep 30, 2023 to Dec 31, 2023v3
  2. Trial status: Not Yet Recruiting to Recruiting Start date: Jul 1, 2023 to Sep 30, 2023 · Primary completion date: Jul 30, 2028 to Aug 30, 2028 · Completion date: Jul 30, 2029 to Aug 30, 2029 · 1 morev2 Show 4 more changesShow less
    • Start date: Jul 1, 2023 to Sep 30, 2023
    • Primary completion date: Jul 30, 2028 to Aug 30, 2028
    • Completion date: Jul 30, 2029 to Aug 30, 2029
    • Site details revised
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography/computed tomography (SPECT/CT). SPECT/CT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.
Trial Details
NCT Number NCT05901545
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: American Cancer Society, Inc.
Conditions Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov