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NCT05945875 · ClinicalTrials.gov registry record · Phase 1

Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With 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
40
Enrollment target
1
Study location

NCT05945875 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 40 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05945875, 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
40 participants
Enrollment target
1
Study location

Study Summary

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.

Interventions

  • PROCEDURE Computed Tomography
  • PROCEDURE Single Photon Emission Computed Tomography
  • DRUG Panitumumab-IRDye800
  • PROCEDURE Resection
  • OTHER Indium In 111 Panitumumab

Study Locations (1)

Tennessee

  • Vanderbilt University/Ingram Cancer Center - Nashville

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2023-10-03
Est. Completion 2028-12-31
Phase Phase 1

Sponsor

Vanderbilt-Ingram Cancer Center

189 total trials

What the Registry Record Tells You About NCT05945875

The ClinicalTrials.gov registry entry for NCT05945875 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (66% lower). The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.

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.

NCT05945875 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT05945875 about?

NCT05945875 is a clinical study titled "Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer". 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 ...

What is the current status of trial NCT05945875?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2023-10-03. Estimated completion is 2028-12-31.

What conditions does trial NCT05945875 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 NCT05945875?

The interventions under investigation include: Computed Tomography (PROCEDURE), Single Photon Emission Computed Tomography (PROCEDURE), Panitumumab-IRDye800 (DRUG), Resection (PROCEDURE), Indium In 111 Panitumumab (OTHER).

Who is sponsoring clinical trial NCT05945875?

This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05945875 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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