(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Eben Rosenthal
Study ID
NCT05747625
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Panitumumab — BIOLOGICAL
    Given IV
  • Zirconium Zr 89 Panitumumab — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Electronic Health Record Review — OTHER
    Ancillary studies

Study Details

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).

Key Dates

Start date
May 9, 2023
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Mar 1, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Diagnostic (89Zr panitumumab PET/CT)
    Patients receive panitumumab IV, 89Zr panitumumab IV, and undergo PET/CT on study

Primary Outcome Measure

Sensitivity of zirconium Zr 89 panitumumab (89Zr-panitumumab [ Time Frame: Up to 7 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232
Vanderbilt-Ingram Service for Timely Access
[email protected]
800-811-8480
Michael Topf, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Vanderbilt University/Ingram Cancer Center· Nashville, TN

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