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NCT05901545 · ClinicalTrials.gov registry record · Phase 1
Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer
A Phase 1 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Vanderbilt-Ingram Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05901545: Recruiting Phase 1 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Vanderbilt-Ingram Cancer Center.
NCT05901545 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma that is actively recruiting participants, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 30 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05901545, a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Vanderbilt-Ingram Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Summarized by grade, severity and type
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Single Photon Emission Computed Tomography
- PROCEDURE Surgical Procedure
- BIOLOGICAL Panitumumab
- OTHER Indium In 111 Panitumumab
Study Locations (1)
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-08-22 |
| Est. Completion | 2029-11-30 |
| Phase | Phase 1 |
What NCT05901545 shows while recruiting
NCT05901545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT05901545 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05901545 about?
NCT05901545 is a clinical study titled "Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer". 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...
What is the current status of trial NCT05901545?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-08-22. Estimated completion is 2029-11-30.
What conditions does trial NCT05901545 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05901545?
The interventions under investigation include: Computed Tomography (PROCEDURE), Single Photon Emission Computed Tomography (PROCEDURE), Surgical Procedure (PROCEDURE), Panitumumab (BIOLOGICAL), Indium In 111 Panitumumab (OTHER).
Who is sponsoring clinical trial NCT05901545?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05901545 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05901545's enrollment target sits among peer trials
30 85th of 124 higher than 36 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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