60 Participants Needed

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

VS
NJ
Overseen ByNicole Jones
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Michael Topf
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr 89 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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking certain heart rhythm medications (like quinidine, procainamide, dofetilide, amiodarone, or sotalol), you may not be eligible to participate.

What data supports the effectiveness of the treatment 89Zr Panitumumab PET/CT Imaging for Head and Neck Cancer?

Research shows that using zirconium-89 labeled antibodies in PET imaging can help detect tumors and guide treatment in head and neck cancer. This approach has been effective in identifying cancer spread in lymph nodes, which is crucial for planning treatment.12345

Is 89Zr-panitumumab safe for use in humans?

89Zr-panitumumab appears safe for use in humans, with reasonable dosimetry estimates for clinical imaging, as shown in a study involving three patients with metastatic colon cancer.12678

How is the drug 89Zr-panitumumab unique for head and neck cancer?

89Zr-panitumumab is unique because it combines a monoclonal antibody, panitumumab, with a radioactive element, zirconium-89, to create a PET imaging agent that targets the epidermal growth factor receptor (EGFR) in tumors. This allows for non-invasive imaging to assess EGFR expression, potentially helping to select patients who might benefit from targeted therapies and to monitor treatment response.12567

Research Team

MT

Michael C. Topf

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with squamous cell carcinoma in the head or neck.
White blood cell count > 3000/mm^3
Hemoglobin >= 9gm/dL
See 6 more

Exclusion Criteria

Magnesium or potassium lower than the normal institutional values
Known hypersensitivity to deferoxamine or any of its components
I am taking medication for heart rhythm problems.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive panitumumab IV, 89Zr panitumumab IV, and undergo PET/CT on study

1-5 days
1 visit (in-person)

Follow-up

Participants are monitored for sensitivity and specificity of 89Zr panitumumab for detection of metastatic lesions

36 months

Treatment Details

Interventions

  • Positron Emission Tomography
  • Zirconium Zr 89 Panitumumab
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Michael Topf

Lead Sponsor

Trials
1
Recruited
60+

Findings from Research

Immuno-PET using (89)Zr-labeled cmAb U36 demonstrated a sensitivity of 72% for detecting lymph node metastases in head and neck squamous cell carcinoma patients, outperforming conventional imaging methods like CT/MRI in certain aspects.
The accuracy of immuno-PET was 93% for detecting operated lymph node levels, indicating its potential as a reliable diagnostic tool for guiding treatment decisions in patients at high risk for metastases.
Performance of immuno-positron emission tomography with zirconium-89-labeled chimeric monoclonal antibody U36 in the detection of lymph node metastases in head and neck cancer patients.Börjesson, PK., Jauw, YW., Boellaard, R., et al.[2015]
In a study involving 18 patients with advanced melanoma or non-small-cell lung cancer, the uptake of 89Zr-labeled pembrolizumab in tumors was found to correlate with treatment response and patient survival, suggesting it could be a useful predictor of therapy effectiveness.
The optimal dose for 89Zr-pembrolizumab was determined to be 5 mg, with the best imaging results observed on day 7 after administration, indicating a potential timeline for monitoring treatment efficacy.
89Zr-pembrolizumab imaging as a non-invasive approach to assess clinical response to PD-1 blockade in cancer.Kok, IC., Hooiveld, JS., van de Donk, PP., et al.[2022]
The first-in-human study of (89)Zr-labeled chimeric monoclonal antibody U36 in 20 patients with head and neck squamous cell carcinoma showed that it was well tolerated, indicating a good safety profile for this immuno-PET approach.
(89)Zr immuno-PET effectively quantified the biodistribution and uptake of the antibody in tumors and organs, supporting its potential use in detecting tumors and planning antibody-based therapies.
Radiation dosimetry of 89Zr-labeled chimeric monoclonal antibody U36 as used for immuno-PET in head and neck cancer patients.Börjesson, PK., Jauw, YW., de Bree, R., et al.[2016]

References

Performance of immuno-positron emission tomography with zirconium-89-labeled chimeric monoclonal antibody U36 in the detection of lymph node metastases in head and neck cancer patients. [2015]
89Zr-pembrolizumab imaging as a non-invasive approach to assess clinical response to PD-1 blockade in cancer. [2022]
Radiation dosimetry of 89Zr-labeled chimeric monoclonal antibody U36 as used for immuno-PET in head and neck cancer patients. [2016]
Quantitative assessment of Zirconium-89 labeled cetuximab using PET/CT imaging in patients with advanced head and neck cancer: a theragnostic approach. [2022]
Preparation of clinical-grade (89) Zr-panitumumab as a positron emission tomography biomarker for evaluating epidermal growth factor receptor-targeted therapy. [2023]
Dosimetry and first human experience with 89Zr-panitumumab. [2020]
A radiopharmaceutical [89Zr]Zr-DFO-nimotuzumab for immunoPET with epidermal growth factor receptor expression in vivo. [2020]
Production of the next-generation positron nuclide zirconium-89 (89 Zr) guided by Monte Carlo simulation and its good quality for antibody labeling. [2021]