Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma


Study First Submitted Date 2021-12-20
Study First Posted Date 2022-01-10
Last Update Posted Date 2022-10-26
Start Month Year October 31, 2023
Primary Completion Month Year March 31, 2025
Verification Month Year October 2022
Verification Date 2022-10-31
Last Update Posted Date 2022-10-26

Detailed Descriptions

Sequence: 20618999
Description The study is an open label, single center, non-randomized, pilot study to determine the efficacy of [89Zr]panitumumab to localize primary tumor in patients with squamous cell carcinoma of the head and neck (HNSCC) that undergo surgery with curative intent compared to standard of care,18F-FDG. Enrolled subjects are clinically and radiographically node negative (cN0) based on the preoperative work-up, which includes a standard of care physical exam and evaluation of the pre-existing imaging data (CT or MRI scan, which may be collected before or during standard of care [18F]FDG imaging). Consenting and Screening phone call Physicians who are study sub-investigators will identify and discuss the study with eligible patients they see in clinic. If interested in the study, sub-investigators will contact study coordinators to discuss further with patients. Interested participants will be consented prior to any study procedures. Consent may be signed during clinical visit or at a more convenient time by the participant. Enrolled patients will be called to discuss the study and complete an MRI screening form. Participants meeting MRI screening criteria will be scheduled for the first visit. Visit 1 (within 5-9 days prior to surgery) During the first visit, consented participants will have a standard of care FDG-PET/MRI, if not already performed, vital signs checked, a 50 mg infusion of panitumumab, and a 1.5 millicurie(mCi) injection of [89Zr]panitumumab. No special patient preparation is required. FDG-PET/MRI administration and imaging: [18F]FDG is an FDA approved radiopharmaceutical and is used as per standard of care in this study. [18F]FDG will be obtained from a commercially licensed Radiopharmacy for this study. If the PET/MRI is unavailable or contraindicated for a participant, FDG-PET/CT may be used at the discretion of the investigator and study radiologist. Panitumumab administration: Participants will receive an intravenous infusion of 50 mg dose of panitumumab over 10 minutes to minimize uptake of the radiotracer in normal tissues. The administration of a fixed small dose of unlabeled antibody to improve tumor-to-normal-tissue (T/N) uptake of the radiolabeled antibody is standard in this type of imaging procedure. Infusion of panitumumab will be prepared by the research pharmacy and administered in the Clinical Research Unit (CRU) infusion area of the Jefferson Tower (JT) according to normal treatment protocol by Oncology personnel appropriately trained and certified to administer chemotherapeutic agents. Following the infusion of panitumumab, participants will be monitored for approximately 30 minutes for infusion reactions and side effects. Because the dose of panitumumab being administered is a fraction, about 1/7 of the dose normally administered as standard treatment, and it is being administered one time per study, no dose modifications for panitumumab are allowed. We do not expect any side effects as a result of the administration of the small dose of panitumumab for this study. However, as it is suggested for therapeutic dose, participants who experience severe dermatological toxicity (National Cancer Institute Common Terminology Criteria (NCI-CTC) grade 3 and higher) or serious infusion reaction (i.e., dyspnea, chest tightness, fever, rigors or hypotension) during panitumumab administration will have the infusion stopped and will be excluded from further participation in the study. Continuation of dosing and continuation in study will be based on the severity and resolution of the event and will be at the discretion of the investigator and the referring/treating physician. Any treatment for an infusion reaction will be administered per institutional practices. [89Zr]Panitumumab administration: At least 60 minutes after injection of panitumumab, participants will receive an injection of [89Zr]Panitumumab in the Advanced Imaging Facility. The administered dose will be 1.5 mCi (±10%) at the time of injection. The amount of injected drug is <1 mg of Panitumumab. The administered intravenous volume of [89Zr]Panitumumab is ≤ 10 mL and will be infused over approximately 1 minute, followed by a saline flush. The infusion will be terminated in any patient who exhibits anaphylaxis, significant dyspnea, or chest pain. Participants will be monitored for 30 minutes after injection. The adverse events to be specifically monitored during the infusions include localized discomfort at the IV injection sites, pain, respiratory difficulties, flushing, dizziness, pruritus/rash, and any other symptoms that could be secondary to an anaphylactic reaction. The subject will be instructed to report any subjective symptoms or sensory changes noted. Participants will be called by study staff within 48 hours to ask about any signs of adverse effects. Visit 2 (within 3-5 days prior to surgery and 2-4 days after [89Zr]Panitumumab injection) Participants will return to the The University of Alabama at Birmingham (UAB) Advanced Imaging Facility for [89Zr]panitumumab-PET/MRI imaging 2 to 4 days after receiving the radiopharmaceutical. Imaging will include a scan of the head and neck region (static) continuing with vertex-to-thigh. No special patient preparation will be requested (i.e., fasting or hydration) on the day of the scans. All participants will be scanned with a calibrated PET/MRI scanner (GE SIGNA 3.0 Tesla PET/MRI scanner; GE Healthcare, Chicago, IL) in the three-dimensional mode. The PET images will be processed using a dedicated workstation (MIM software; MIM, Cleveland, Ohio or Advantage Workstation; GE Healthcare, Chicago, IL). Images will be analyzed by a nuclear medicine physician who will be blinded from the clinical information on target lesion distribution. Investigator (CoI: Dr. McConathy) blinded to the imaging agent used (FDG or [89Zr]panitumumab) and to clinical disease status will visually inspect de-identified PET/MRI images and draw regions of interest (ROI's) over suspicious lesions. Image processing software will calculate standard uptake value (SUV)max and Tumor to background radio (TBR) values. If the PET/MRI is unavailable or contraindicated for a participant, the PET/CT may be used at the discretion of the investigator and study radiologist. Standard of Care Surgical Resection and Follow up Patients will undergo standard of care surgical resection as directed by treating physician. Histological assessments and other post-surgical information will be obtained by follow up review of patient's medical records. Histological assessment Routine H&E staining will be performed for histological assessment by a board-certified pathologist to determine the presence/absence of tumor and tumor dimensions. Findings will be compared to PET imaging findings. Subsequently, histological findings will be correlated with autoradiography findings using slide-mounted sections obtained from paraffin-embedded blocks. Immunohistochemistry on unstained lymph node sections will be performed to evaluate Estimated Glomerular Filtration Rate (eGFR) expression, tumor density (anti-pan cytokeratin), vessel density, and histiocyte presence. For the latter we will look amongst others at macrophages, T- and B-cells. Stained slides will be imaged using the Bio-Imagene (Ventana Medical Systems) optical scanner. Findings will then be correlated to the PET imaging results. Additional sections will be collected as needed. Clinical and pathological response data will be collected at the end of the treatment period. Once the data is collected, no further follow up will be required for the patients. Future Use of Stored Specimens and Data Data and samples collected for this study will be analyzed and stored on site. After the study is completed, the de-identified, archived data will be stored on site, for use by other researchers including those outside of the study if participant allows. With participant approval, when the study is completed, access to study data and/or samples will be provided through the Volker Hall Tissue Bank.


Sequence: 199052622
Name UAB
City Birmingham
State Alabama
Zip 35249
Country United States

Facility Contacts

Sequence: 27990609
Facility Id 199052622
Contact Type primary
Name Sebastian Eady
Phone 205-966-2636

Facility Investigators

Sequence: 18259630 Sequence: 18259631
Facility Id 199052622 Facility Id 199052622
Role Principal Investigator Role Sub-Investigator
Name Suzanne Lapi, PhD Name Jason Warram, PhD

Browse Interventions

Sequence: 95541649 Sequence: 95541650 Sequence: 95541651
Mesh Term Panitumumab Mesh Term Antineoplastic Agents, Immunological Mesh Term Antineoplastic Agents
Downcase Mesh Term panitumumab Downcase Mesh Term antineoplastic agents, immunological Downcase Mesh Term antineoplastic agents
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 51908827
Name Head and Neck Squamous Cell Carcinoma
Downcase Name head and neck squamous cell carcinoma

Id Information

Sequence: 39953084
Id Source org_study_id
Id Value IRB-300008612


Sequence: 42345664
Name United States
Removed False

Design Groups

Sequence: 55316408
Group Type Experimental
Title [89Zr]panitumumab-PET/MRI patients
Description All study patients will receive [89Zr]Panitumumab-PET/MRI imaging.


Sequence: 52223603
Intervention Type Drug
Name [89Zr]Panitumumab Tracer
Description All patients entered into the study will have [89Zr]Panitumumab-PET/MRI imaging.

Design Outcomes

Sequence: 176477632
Outcome Type primary
Measure Image Quality
Time Frame 5-9 days prior to surgery
Description Diagnostic image quality of [89Zr]Panitumumab PET imaging in patients with newly diagnosed HNSCC. Standardized Uptake Values (SUVs) will be measured.

Browse Conditions

Sequence: 192432224 Sequence: 192432225 Sequence: 192432226 Sequence: 192432227 Sequence: 192432228 Sequence: 192432229 Sequence: 192432230 Sequence: 192432231 Sequence: 192432232
Mesh Term Carcinoma Mesh Term Carcinoma, Squamous Cell Mesh Term Squamous Cell Carcinoma of Head and Neck Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Neoplasms, Squamous Cell Mesh Term Head and Neck Neoplasms Mesh Term Neoplasms by Site
Downcase Mesh Term carcinoma Downcase Mesh Term carcinoma, squamous cell Downcase Mesh Term squamous cell carcinoma of head and neck Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term neoplasms, squamous cell Downcase Mesh Term head and neck neoplasms Downcase Mesh Term neoplasms by site
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48072128
Agency Class OTHER
Lead Or Collaborator lead
Name University of Alabama at Birmingham

Overall Officials

Sequence: 29131197
Role Principal Investigator
Name Suzanne Lapi, PhD
Affiliation University of Alabama at Birmingham

Central Contacts

Sequence: 11951419 Sequence: 11951420
Contact Type primary Contact Type backup
Name Sebastian Eady, BS Name Chase Bower
Phone 204-996-2636 Phone 205-645-4457
Email Email
Role Contact Role Contact

Design Group Interventions

Sequence: 67814814
Design Group Id 55316408
Intervention Id 52223603


Sequence: 30609503
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria: Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck Subjects newly diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects are to be staged clinically and radiographically node negative (cN0) Planned standard of care surgery with curative intent for squamous cell carcinoma Age > 18 years Have acceptable hematologic status, coagulation status (11 to 13.5 seconds. international normalized ratio (INR) of 0.8 to 1.1), kidney function, and liver function including the following clinical results: Hemoglobin ≥ 9 gm/dL White blood cell count ≥ 3000/mm3 Platelet count ≥ 100,000/mm3 Serum creatinine ≤ 1.5 times upper reference range alanine transaminase (ALT) (SGPT) 7-56 units/liter, aspartate aminotransferase (AST) (SGOT) 5-40 units/liter. Exclusion Criteria: Received an investigational drug within 30 days prior to the first dose of [89Zr]panitumumab. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment. Previous HNSCC resection. History of infusion reactions to monoclonal antibody therapies. Pregnant or breast-feeding women. Magnesium (<1.7 mg/dL) or potassium (<3.6 mmol/L) lower than the normal institutional values. Subjects receiving Class I-A (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. Severe renal disease or anuria (Creatinine within normal institutional limits OR Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels). Known hypersensitivity to panitumumab or any of its components. Weight over 350 lbs., due to the scanner bore size. Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos).
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253944571
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1


Sequence: 30356757
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Diagnostic
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28728687
Responsible Party Type Principal Investigator
Name Suzanne E. Lapi, PhD
Title Professor, Advanced Imaging Facility, Division of Advanced Medical Imaging Research
Affiliation University of Alabama at Birmingham