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89Zr Panitumumab PET/CT Imaging for Head and Neck Cancer

Phase 1
Recruiting
Led By Michael Topf, MD
Research Sponsored by Michael Topf
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
No Placebo-Only Group

Summary

This trial seeks to test a new imaging agent to help diagnose spread of head & neck cancer to other parts of the body. Participants will get the agent and then get scans to compare to standard of care imaging.

Who is the study for?
This trial is for adults over 19 with head and neck squamous cell carcinoma, who have indeterminate metastatic lesions as shown by PET/CT scans. They must have a certain level of hemoglobin, kidney function (eGFR), and platelet count. Excluded are those with recent severe heart conditions, renal disease, pulmonary issues, pregnant or breastfeeding women, or allergies to similar drugs.
What is being tested?
The study tests an imaging agent called 89Zr panitumumab combined with PET/CT scanning to detect the spread of cancer in patients with head and neck squamous cell carcinoma. It aims to see if this new method is more accurate than standard MRI, CT or PET/CT scans in identifying metastases.
What are the potential side effects?
Potential side effects may include reactions related to the infusion of monoclonal antibodies like Panitumumab such as allergic responses. Since it's an imaging test involving radiation exposure from Zirconium Zr 89 Panitumumab there might be risks associated with that as well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sensitivity of zirconium Zr 89 panitumumab (89Zr-panitumumab
Secondary study objectives
Sensitivity of 89Zr-panitumumab
Specificity of 89Zr-panitumumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (89Zr panitumumab PET/CT)Experimental Treatment5 Interventions
Patients receive panitumumab IV, 89Zr panitumumab IV, and undergo PET/CT on study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Panitumumab
2017
Completed Phase 3
~7150
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

Michael TopfLead Sponsor
Michael Topf, MDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center

Media Library

Diagnostic (89Zr panitumumab PET/CT) Clinical Trial Eligibility Overview. Trial Name: NCT05747625 — Phase 1
Head and Neck Squamous Cell Carcinoma Research Study Groups: Diagnostic (89Zr panitumumab PET/CT)
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Diagnostic (89Zr panitumumab PET/CT) Highlights & Side Effects. Trial Name: NCT05747625 — Phase 1
Diagnostic (89Zr panitumumab PET/CT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05747625 — Phase 1
~36 spots leftby Feb 2027
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