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NCT05747625 · ClinicalTrials.gov registry record · Phase 1
(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma
A Phase 1 study of Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma, sponsored by Eben Rosenthal.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05747625: Recruiting Phase 1 study of Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma, sponsored by Eben Rosenthal.
NCT05747625 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma that is actively recruiting participants, run by Eben Rosenthal. The registered enrollment target is 60 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (49% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05747625, a Phase 1 study of Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma, is actively recruiting participants, sponsored by Eben Rosenthal.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 panitumumab \[89Zr panitumumab\]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer. Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions. Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT).
Primary Outcome
The total number of head and neck squamous cell carcinoma lesions accurately detected by 89Zr-panitumumab using positron emission tomography (PET)/computed tomography (CT) imaging (test) will be compared with lesions identified as positive during the 36 +/- 6 month follow-up period (gold standard). Significance will be assessed at an alpha level of 0.05 and, to assess uncertainty, 95% confidence intervals will be provided for all estimates.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Electronic Health Record Review
- BIOLOGICAL Panitumumab
- DRUG Zirconium Zr 89 Panitumumab
Study Locations (1)
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-05-09 |
| Est. Completion | 2030-03-01 |
| Phase | Phase 1 |
What NCT05747625 shows while recruiting
NCT05747625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 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 (49% lower).
The record links to 3 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.
NCT05747625 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05747625 about?
NCT05747625 is a clinical study titled "(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma". The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 panitumumab \[89Zr panitumumab\]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places ...
What is the current status of trial NCT05747625?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2023-05-09. Estimated completion is 2030-03-01.
What conditions does trial NCT05747625 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT05747625?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Electronic Health Record Review (OTHER), Panitumumab (BIOLOGICAL), Zirconium Zr 89 Panitumumab (DRUG).
Who is sponsoring clinical trial NCT05747625?
This trial is sponsored by Eben Rosenthal, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05747625 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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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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