[89Zr]Panitumumab Imaging for Head and Neck Cancer

Overseen By Chase Bower

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Must not be taking: Antiarrhythmics

Disqualifiers: Pregnancy, Severe renal disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new imaging method using Zirconium-89 (89Zr) panitumumab tracer can more accurately show the size and location of head and neck cancer tumors compared to standard imaging. This study focuses solely on imaging and will not alter the cancer treatment plan. Individuals with a recent diagnosis of head and neck squamous cell carcinoma who are scheduled for surgery may be suitable candidates. The trial seeks participants whose cancer has not spread to nearby lymph nodes. As an Early Phase 1 trial, this research focuses on understanding how this new imaging method functions in people, offering participants a chance to contribute to groundbreaking advancements in cancer diagnostics.

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 method is safe for patients with head and neck cancer?

Research has shown that 89Zr-panitumumab, used in imaging, is generally safe. Studies indicate that it helps doctors see tumors more clearly and distinguish them from other findings on scans. Other research found that 89Zr-panitumumab did not cause any major side effects, indicating it is well-tolerated by patients when used for imaging. Although this tracer is still under study, early results suggest it is safe for this purpose. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for head and neck cancer, which typically involves surgery, radiation, and chemotherapy, [89Zr]Panitumumab offers a unique approach by acting as a tracer for imaging. This tracer is linked to Panitumumab, an antibody that targets the epidermal growth factor receptor (EGFR), which is often overexpressed in these cancers. By using PET/MRI imaging, this method allows for precise visualization of cancerous tissues, potentially improving treatment planning and monitoring. Researchers are excited because this could lead to more personalized and effective treatment strategies, minimizing unnecessary interventions and improving patient outcomes.

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

Research has shown that the [89Zr]Panitumumab tracer used in PET/MRI scans could aid in diagnosing head and neck cancer. Studies have found it detects tumors more accurately than traditional imaging methods. Specifically, [89Zr]Panitumumab can better distinguish between cancerous and non-cancerous areas, potentially allowing doctors to identify cancerous spots more precisely. In this trial, all participants will undergo [89Zr]Panitumumab-PET/MRI imaging. Although researchers are still studying this imaging method, early results suggest it could become a valuable tool for diagnosing head and neck cancers. ^{1 2 4 5 6}

Who Is on the Research Team?

Suzanne Lapi, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults over 18 with newly diagnosed head and neck squamous cell carcinoma, scheduled for surgery. Participants must have normal organ function tests, no history of severe heart or liver conditions within the past 6 months, not be pregnant or breastfeeding, and cannot exceed a weight limit due to scanner size.

Inclusion Criteria

I am scheduled for surgery to remove my squamous cell carcinoma.

I am older than 18 years.

I am scheduled for surgery for my newly diagnosed head or neck cancer.

Exclusion Criteria

Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos).

Magnesium (<1.7 mg/dL) or potassium (<3.6 mmol/L) lower than the normal institutional values

Weight over 350 lbs., due to the scanner bore size

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (phone call)

Imaging Preparation

Participants receive a standard of care FDG-PET/MRI, vital signs check, and infusion of panitumumab followed by injection of [89Zr]Panitumumab

1 day

1 visit (in-person)

Imaging

Participants undergo [89Zr]panitumumab-PET/MRI imaging 2 to 4 days after receiving the radiopharmaceutical

2-4 days

1 visit (in-person)

Surgical Resection and Follow-up

Patients undergo standard of care surgical resection and follow-up review of medical records for histological assessments

5-9 days

What Are the Treatments Tested in This Trial?

Interventions

• [89Zr]Panitumumab Tracer

Trial Overview [89Zr]Panitumumab PET/MRI imaging is being tested against standard [18F-FDG] PET/MRI to see if it's better at finding the exact size and location of tumors in patients with head and neck cancer. This study will not affect treatment plans as it's only for imaging purposes.

How Is the Trial Designed?

Group I: [89Zr]panitumumab-PET/MRI patients Experimental Treatment 1 Intervention

All study patients will receive \[89Zr\]Panitumumab-PET/MRI imaging.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

In a phase 2 trial involving 152 patients with locally advanced squamous-cell carcinoma of the head and neck, the combination of chemoradiotherapy showed better local-regional control at 2 years (61%) compared to radiotherapy plus panitumumab (51%).

The study found that while both treatment groups experienced significant adverse events, the rates of serious adverse events were similar, suggesting that panitumumab does not provide a sufficient benefit to replace cisplatin in this treatment setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Panitumumab plus radiotherapy versus chemoradiotherapy in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-2): a randomised, controlled, open-label phase 2 trial. Giralt, J., Trigo, J., Nuyts, S., et al.[2022]

The study involved 14 adult patients with head and neck squamous cell carcinoma (HNSCC) and demonstrated that the tumor-targeted radiotracer 89Zr-pan PET/CT significantly improved diagnostic specificity to 96.3%, compared to 74.1% for 18F-FDG PET/CT alone.

89Zr-pan PET/CT was found to be safe, with only one minor adverse event reported, and it effectively helped differentiate between incidental findings and true cancerous lesions, enhancing the localization of metastatic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

89Zr-panitumumab Combined With 18F-FDG PET Improves Detection and Staging of Head and Neck Squamous Cell Carcinoma. Lee, YJ., van den Berg, NS., Duan, H., et al.[2023]

Panitumumab, a fully human monoclonal antibody targeting EGFR, shows promising results in radioimmunotherapy for EGFR-positive head and neck cancer, with a single dose of 200 microCi (90)Y-DOTA-panitumumab leading to almost complete tumor regression in a mouse model.

The treatment demonstrated significant tumor growth delay and improved survival, while also showing limited systemic toxicity, indicating its potential as a safe and effective option for treating EGFR-positive solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidermal growth factor receptor-targeted radioimmunotherapy of human head and neck cancer xenografts using 90Y-labeled fully human antibody panitumumab. Liu, Z., Liu, Y., Jia, B., et al.[2023]

In a trial involving 46 patients with high-risk, resected head and neck squamous cell carcinoma, the combination of the monoclonal antibody panitumumab with cisplatin chemoradiotherapy showed a promising 2-year progression-free survival rate of 70%.

The treatment was found to be tolerable, with 32% of patients experiencing severe toxicities, indicating that while the regimen is effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of post-operative radiotherapy with concurrent cisplatin plus panitumumab in patients with high-risk, resected head and neck cancer. Ferris, RL., Geiger, JL., Trivedi, S., et al.[2020]

(89)Zr-DFO-panitumumab can be produced with high radiochemical purity and specific activity, allowing for effective imaging of HER1 expression in tumors, particularly in breast cancer models with varying HER1 levels.

Immuno-PET imaging demonstrated a strong correlation between HER1 expression and tumor uptake of (89)Zr-DFO-panitumumab, suggesting its potential as a clinically feasible tool for targeting and visualizing HER1-expressing tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zirconium-89 labeled panitumumab: a potential immuno-PET probe for HER1-expressing carcinomas. Bhattacharyya, S., Kurdziel, K., Wei, L., et al.[2022]

Panitumumab is a human monoclonal antibody that targets the epidermal growth factor receptor (EGFR), which plays a crucial role in the growth and spread of cancer cells, specifically in metastatic colorectal carcinoma.

It is used as a single-agent treatment for patients whose cancer has progressed after standard chemotherapy regimens, including fluoropyrimidine, oxaliplatin, and irinotecan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Panitumumab (vectibix). Gemmete, JJ., Mukherji, SK.[2021]

In a phase I study involving 19 patients with advanced squamous cell carcinoma of the head and neck, the combination of panitumumab, carboplatin, and escalating doses of paclitaxel with intensity-modulated radiotherapy (IMRT) showed a high overall complete clinical response rate of 95%.

The treatment was generally well tolerated, with the maximum tolerated dose of paclitaxel identified at 30 mg/m², although all patients experienced significant side effects like mucositis and oral pain, indicating the need for careful management of these toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I dose-finding study of paclitaxel with panitumumab, carboplatin and intensity-modulated radiotherapy in patients with locally advanced squamous cell cancer of the head and neck. Wirth, LJ., Allen, AM., Posner, MR., et al.[2020]

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]

Citations

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

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

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 ... We found that the use of 89Zr-pan PET/CT led to improved specificity and positive predictive value in detection of metastatic head and neck ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05747625

NCT05747625 | (89Zr Panitumumab) With PET/CT for ... Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging ...

4. withpower.com withpower.com/trial/phase-2-carcinoma-5-2022-a1750

Zr-Panitumumab Imaging for Head and Neck Cancer The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous ...

5. vicc.org vicc.org/clinical-trials/protocol-vicchn2279

(89Zr Panitumumab) With PET/CT for Diagnosing ... Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging ...

6. withpower.com withpower.com/trial/early-phase-1-carcinoma-squamous-cell-2-2022-dcb92

[89Zr]Panitumumab Imaging for Head and Neck Cancer This trial tests a new imaging method using a special radioactive substance to better locate and measure head and neck tumors in patients.