[89Zr]Panitumumab Imaging for Head and Neck Cancer
Recruiting in Palo Alto (17 mi)
Overseen BySuzanne Lapi, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of Alabama at Birmingham
Must not be taking: Antiarrhythmics
Disqualifiers: Pregnancy, Severe renal disease, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests a new imaging method using a special radioactive substance to better locate and measure head and neck tumors in patients. It aims to provide clearer images than the current standard method. The study involves injecting a small amount of a drug to help the radioactive substance attach to the tumor cells, making them more visible on scans.
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 drug [89Zr]Panitumumab Tracer for head and neck cancer?
Research shows that panitumumab, a component of the drug, has been used effectively in combination with other treatments for head and neck cancer, improving outcomes in some cases. Additionally, zirconium-89, used in similar imaging studies, has shown promise in detecting cancer spread, which can help guide treatment decisions.
12345Is [89Zr]Panitumumab safe for use in humans?
Panitumumab, also known as Vectibix, is a human antibody approved for treating certain types of cancer, and studies have shown it has limited systemic toxicity, meaning it generally doesn't cause widespread harm in the body. However, specific safety data for [89Zr]Panitumumab in humans is not detailed in the available research.
14678How is [89Zr]Panitumumab Imaging different from other treatments for head and neck cancer?
[89Zr]Panitumumab Imaging is unique because it combines a monoclonal antibody, panitumumab, with a radioactive element, zirconium-89, to create a PET imaging probe. This allows for non-invasive imaging of tumors that express the HER1 receptor, providing detailed information about the cancer's location and potentially guiding targeted therapy.
13469Eligibility Criteria
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.
+8 more
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
+9 more
Trial Timeline
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
Participant Groups
[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.
1Treatment groups
Experimental Treatment
Group I: [89Zr]panitumumab-PET/MRI patientsExperimental Treatment1 Intervention
All study patients will receive \[89Zr\]Panitumumab-PET/MRI imaging.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UABBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
Panitumumab (vectibix). [2021]Panitumumab (Vectibix), is a human monoclonal antibody EGFR antagonist indicated as a single agent for the treatment of metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens. This article will present the mechanism of action as well as the clinical role for this monoclonal antibody.
Phase II trial of post-operative radiotherapy with concurrent cisplatin plus panitumumab in patients with high-risk, resected head and neck cancer. [2020]Treatment intensification for resected, high-risk, head and neck squamous cell carcinoma (HNSCC) is an area of active investigation with novel adjuvant regimens under study. In this trial, the epidermal growth-factor receptor (EGFR) pathway was targeted using the IgG2 monoclonal antibody panitumumab in combination with cisplatin chemoradiotherapy (CRT) in high-risk, resected HNSCC.
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. [2022]We aimed to compare panitumumab, a fully human monoclonal antibody against EGFR, plus radiotherapy with chemoradiotherapy in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck.
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]Immuno-positron emission tomography (PET), the combination of PET with monoclonal antibodies (mAb), is an attractive option to improve tumor detection and to guide mAb-based therapy. The long-lived positron emitter zirconium-89 ((89)Zr) has ideal physical characteristics for immuno-PET with intact mAbs but has never been used in a clinical setting. In the present feasibility study, we aimed to evaluate the diagnostic imaging performance of immuno-PET with (89)Zr-labeled-chimeric mAb (cmAb) U36 in patients with squamous cell carcinoma of the head and neck (HNSCC), who were at high risk of having neck lymph node metastases.
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. [2020]Panitumumab has the potential to improve the therapeutic ratio of concurrent chemoradiotherapy for squamous cell carcinoma of the head and neck (SCCHN).
Zirconium-89 labeled panitumumab: a potential immuno-PET probe for HER1-expressing carcinomas. [2022]Anti-HER1 monoclonal antibody (mAb), panitumumab (Vectibix) is a fully human mAb approved by the FDA for the treatment of epidermal growth factor receptor (EGFR, HER1)-expressing colorectal cancers. By combining the targeted specificity of panitumumab with the quantitative in vivo imaging capabilities of PET, we evaluated the potential of (89)Zr-DFO-panitumumab PET/CT imaging and performed non-invasive, in vivo imaging of HER1 expression and estimated human dosimetry.
89Zr-panitumumab Combined With 18F-FDG PET Improves Detection and Staging of Head and Neck Squamous Cell Carcinoma. [2023]Determine the safety and specificity of a tumor-targeted radiotracer (89Zr-pan) in combination with 18F-FDG PET/CT to improve diagnostic accuracy in head and neck squamous cell carcinoma (HNSCC).
Epidermal growth factor receptor-targeted radioimmunotherapy of human head and neck cancer xenografts using 90Y-labeled fully human antibody panitumumab. [2023]Panitumumab (ABX-EGF or Vectibix), the first fully human monoclonal antibody targeting epidermal growth factor receptor (EGFR), was approved by the Food and Drug Administration for treatment of patients with metastatic colorectal cancer. Here, we report for the first time the radioimmunotherapy (RIT) of EGFR-positive human head and neck cancer in a nude mouse model using pure beta(-) emitter (90)Y-labeled panitumumab. Biodistribution and planar gamma-imaging studies were carried out with (111)In-DOTA-panitumumab. The RIT efficacy of (90)Y-DOTA-panitumumab was evaluated in UM-SCC-22B tumor model. CD31, Ki67, terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling, and H&E staining were done on UM-SCC-22B tumor sections after treatment. The tumor uptake of (111)In-DOTA-panitumumab in UM-SCC-22B tumor-bearing nude mice was 26.10 +/- 4.93, 59.11 +/- 7.22, 44.57 +/- 9.80, 40.38 +/- 7.76, and 14.86 +/- 7.23 % injected dose per gram of tissue at 4, 24, 72, 120, and 168 hours after injection, respectively. Immunotherapy with cold panitumumab (four doses of 10 mg/kg) did not cause significant antitumor effect. RIT with a single dose of 100 microCi (90)Y-DOTA-panitumumab caused significant tumor growth delay and improved the survival in UM-SCC-22B tumor model. A single dose of 200 microCi (90)Y-DOTA-panitumumab led to almost complete tumor regression (tumor volumes were 34.83 +/- 11.11 mm(3) and 56.02 +/- 39.95 mm(3) on days 0 and 46 after treatment, respectively). Histopathologic analysis of tumors and normal organs further validated the therapeutic efficacy and limited systemic toxicity of (90)Y-DOTA-panitumumab. The high tumor uptake and prolonged tumor retention, as well as effective therapy, reveal that (90)Y-DOTA-panitumumab may be a promising radioimmunotherapeutic agent to treat EGFR-positive solid tumors.
Preparation of clinical-grade (89) Zr-panitumumab as a positron emission tomography biomarker for evaluating epidermal growth factor receptor-targeted therapy. [2023]Panitumumab is a fully human monoclonal antibody approved for the treatment of epidermal growth factor receptor (EGFR) positive colorectal cancer. Recently, panitumumab has been radiolabeled with (89) Zr and evaluated for its potential to be used as immuno-positron emission tomography (PET) probe for EGFR positive cancers. Interesting preclinical results published by several groups of researchers have prompted us to develop a robust procedure for producing clinical-grade (89) Zr-panitumumab as an immuno-PET probe to evaluate EGFR-targeted therapy. In this process, clinical-grade panitumumab is bio-conjugated with desferrioxamine chelate and subsequently radiolabeled with (89) Zr resulting in high radiochemical yield (>70%, n = 3) and purity (>98%, n = 3). All quality control (QC) tests were performed according to United States Pharmacopeia specifications. QC tests showed that (89) Zr-panitumumab met all specifications for human injection. Herein, we describe a step-by-step method for the facile synthesis and QC tests of (89) Zr-panitumumab for medical use. The entire process of bioconjugation, radiolabeling, and all QC tests will take about 5 h. Because the synthesis is fully manual, two rapid, in-process QC tests have been introduced to make the procedure robust and error free.