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Dual Imaging for Head and Neck Cancer

Phase 1

Recruiting

Led By Eben Rosenthal, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

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 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses two imaging techniques to detect cancer in head & neck. 111In-panitumumab with SPECT/CT & panitumumab-IRDye800 fluorescence imaging, to improve detection of disease.

Who is the study for?

This trial is for adults over 19 with any stage of head and neck squamous cell carcinoma, scheduled for surgery. It includes those with recurrent disease or a new primary cancer who can sign consent. Excluded are pregnant individuals, those with certain heart risks, severe kidney issues, recent serious cardiovascular events, allergies to iodine or past bad reactions to monoclonal antibodies.

What is being tested?

The trial tests two imaging techniques in detecting head and neck cancer during surgery: a radioactive agent (111In-panitumumab) used with SPECT/CT scans and a fluorescent dye-linked antibody (panitumumab-IRDye800). The goal is to see if combining these methods improves disease detection.

What are the potential side effects?

Potential side effects may include allergic reactions to the imaging agents or dyes used, as well as typical risks associated with exposure to radiation from the SPECT/CT scan such as nausea and increased risk of future cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Number of grade 2 or higher adverse events

Secondary study objectives

Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes

Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved margins

Specificity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes

+1 more

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 (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT)Experimental Treatment6 Interventions

Patients receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Resection

2020

Completed Phase 2

~1440