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

Overseen By Kyrionna Golliday

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eben Rosenthal

Must not be taking: Antiarrhythmics

Disqualifiers: MI, CVA, CHF, liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1-5 days

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new imaging method to better detect the spread of head and neck cancer. Researchers are using Zirconium Zr 89 Panitumumab, an experimental imaging agent, combined with PET/CT scans to determine if it provides clearer images of cancer spread compared to standard scans. The trial focuses on patients with head and neck squamous cell carcinoma who have uncertain cancer spread as shown by current scans. Individuals with this type of cancer and unclear scan results might be suitable candidates for the trial. As a Phase 1 trial, the research focuses on understanding how this new imaging method works in people, offering participants the opportunity to be among the first to benefit from this innovative approach.

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 prior data suggests that this imaging technique is safe for diagnosing head and neck cancer?

Research has shown that using 89Zr panitumumab with PET/CT scans is safe for patients. Studies have found that this imaging agent helps doctors locate certain cancer cells without causing harm. Previous studies reported no major safety issues or serious side effects for patients. This makes it a promising tool for detecting cancer spread non-invasively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 89Zr Panitumumab PET/CT imaging technique for head and neck cancer because it offers a new way to visualize tumors. Unlike traditional imaging methods, this approach uses Zirconium Zr 89-labeled panitumumab, an innovative radioactive tracer that specifically targets cancer cells. This specificity could lead to more accurate detection and better treatment planning. By providing clearer images of cancerous areas, it may improve the precision of interventions and potentially lead to better outcomes for patients.

What evidence suggests that this imaging method is effective for detecting metastatic head and neck cancer?

Research shows that zirconium Zr89 panitumumab is a promising tool for detecting tumors in head and neck cancer. Early studies found that this imaging agent can highlight tumors by targeting EGFR, a protein often present in high amounts in these cancers. In this trial, participants will receive zirconium Zr89 panitumumab and undergo PET/CT imaging. One study showed that zirconium Zr89 panitumumab successfully identified tumors in patients, providing clearer results than standard imaging methods. This suggests it could help doctors detect cancer spread more easily, simplifying the identification of affected areas. Overall, zirconium Zr89 panitumumab shows potential for more accurate cancer imaging. ^{2 3 4 5 6}

Who Is on the Research Team?

Michael C. Topf

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Positron Emission Tomography
• Zirconium Zr 89 Panitumumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Diagnostic (89Zr panitumumab PET/CT) Experimental Treatment 5 Interventions

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

Who Is Running the Clinical Trial?

Eben Rosenthal

Lead Sponsor

Trials

9

Recruited

200+

Michael Topf

Lead Sponsor

Trials

1

Recruited

60+

Vanderbilt-Ingram Cancer Center

Collaborator

Trials

221

Recruited

64,400+

Published Research Related to This Trial

89Zr-panitumumab is a promising immuno-PET radiotracer that can non-invasively assess EGFR expression in tumors, potentially aiding in patient selection for targeted therapies and monitoring treatment responses.

In a study involving three patients with metastatic colon cancer, the estimated effective dose of 89Zr-panitumumab was found to be safe, with dosimetry estimates comparable to those from animal studies, indicating its feasibility for clinical imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetry and first human experience with 89Zr-panitumumab. Lindenberg, L., Adler, S., Turkbey, IB., et al.[2020]

The radiopharmaceutical [89Zr]Zr-DFO-nimotuzumab was successfully prepared with high radiochemical yield (>90%) and purity (>99%), demonstrating its potential for effective imaging of EGFR in glioma.

In vivo studies showed that [89Zr]Zr-DFO-nimotuzumab provided excellent image contrast in PET/CT imaging, with significant tumor uptake, indicating its utility for assessing EGFR status in glioma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A radiopharmaceutical [89Zr]Zr-DFO-nimotuzumab for immunoPET with epidermal growth factor receptor expression in vivo. Tang, Y., Hu, Y., Liu, W., et al.[2020]

The study successfully developed optimized methods for producing and purifying the novel positron nuclide zirconium-89 (89Zr), achieving a production rate of 0.92 ± 0.12 mCi/μA·h after a 1- to 2-hour bombardment, which is significant for immunological imaging.

The labeled compound [89Zr]Zr-DFO-trastuzumab demonstrated high radiochemical purity (>95%) and stability, indicating its potential for effective tumor molecular imaging applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Production of the next-generation positron nuclide zirconium-89 (89 Zr) guided by Monte Carlo simulation and its good quality for antibody labeling. Wang, F., Ding, J., Guo, X., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 17 patients with locally advanced head and neck squamous cell carcinomas, PET imaging with 89Zr-cetuximab revealed significant variability in drug uptake, suggesting that tumor accessibility may influence treatment response to cetuximab.

The study found that higher EGFR expression correlated with increased uptake of cetuximab, indicating that measuring cetuximab uptake could provide valuable insights beyond traditional EGFR expression levels, although further validation is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative assessment of Zirconium-89 labeled cetuximab using PET/CT imaging in patients with advanced head and neck cancer: a theragnostic approach. Even, AJ., Hamming-Vrieze, O., van Elmpt, W., et al.[2022]

Panitumumab, a monoclonal antibody for treating EGFR positive colorectal cancer, has been successfully radiolabeled with (89)Zr, showing high radiochemical yield (>70%) and purity (>98%), making it suitable for use as an immuno-PET probe.

The developed synthesis and quality control process for (89)Zr-panitumumab is efficient, taking about 5 hours, and includes rapid in-process QC tests to ensure safety and reliability for human injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparation of clinical-grade (89) Zr-panitumumab as a positron emission tomography biomarker for evaluating epidermal growth factor receptor-targeted therapy. Wei, L., Shi, J., Afari, G., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05747625

NCT05747625 | (89Zr Panitumumab) With PET/CT for ... The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 panitumumab [89Zr panitumumab]) with positron ...

2. aacrjournals.org aacrjournals.org/clincancerres/article/28/20/4425/709598/89Zr-panitumumab-Combined-With-18F-FDG-PET

89 Zr-panitumumab Combined With 18 F-FDG PET Improves ... In this early-phase clinical study, we studied a tumor-targeted PET radiopharmaceutical – zirconium-89 panitumumab (89Zr-pan) – in 14 patients ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4329987/

Development and Characterization of 89Zr-Labeled ... MicroPET/CT imaging studies demonstrated a high intensity of 89Zr-panitumumab in A431 and HCT 116 tumors in comparison with the EGFR-negative tumors.

4. nature.com nature.com/articles/s41598-022-23531-z

89 Zr-panitumumab PET imaging for preoperative ... The use of 89 Zr-panitumumab for PET-CT is a non-invasive method to monitor EGFR expression providing a useful way to identify EGFR-expressing tumors.

5. dicom.nema.org ftp://dicom.nema.org/medical/dicom/DataSets/WG30/Frederick/PETCT/TwoMouseZr89PET_20110826/Documentation/Zirconium-89%20labeled%20panitumumab_a%20potential%20immuno-PET%20probe%20for%20HER-1%20expressing%20carcinomas.pdf

Zirconium-89 labeled panitumumab Currently, it is being evaluated in patients with other types of HER1-expressing cancers, such as breast, lung, head and neck, renal, and ovarian tumors [12].

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35929985/

89Zr-panitumumab Combined With 18F-FDG PET Improves ... Conclusions: 89Zr-pan PET/CT imaging is safe and may be valuable in discriminating incidental findings identified on 18F-FDG PET/CT from true ...