Head-and-neck Squamous Cell CarcinomaPhase 2NCT05423197
89Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in HNSCC
A Phase 2 study testing 89Zr-panitumumab IV and Panitumumab in people with Head-and-neck Squamous Cell Carcinoma, run by Andrei Iagaru at 1 site in United States.
Trial summary
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 cell carcinoma (HNSCC). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Head-and-neck Squamous Cell Carcinoma
- What is being tested?
- 89Zr-panitumumab IV and Panitumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years.
- Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
- Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
- Must have standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions.
- Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results:
- Hemoglobin ≥ 9gm/dL
Show all 11Show fewer
- White blood cell count > 3000/mm3
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 times upper reference range
- PTT = 11.5 - 14.4 seconds
- INR = 0.9 - 1.2
Who cannot join
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- History of infusion reactions to other monoclonal antibody therapies
- Pregnant or breastfeeding
- Magnesium or potassium lower than the normal institutional values
- Subjects receiving Class IA (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
- Known hypersensitivity to deferoxamine or any of its components
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Cancer Institute
San Francisco, California, 94305
About this study
Official title: Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
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 cell carcinoma (HNSCC).
Read the detailed description
PRIMARY OBJECTIVE(S):
- Determine the sensitivity and specificity of 89Zr-panitumumab for the detection of suspected metastatic lesions
SECONDARY OBJECTIVE(S):
- Compare sensitivity and specificity of 18F-FDG-PET/CT and 89Zr-panitumumab-PET/CT for detection of suspected metastatic lesions
- Conditions
- Head-and-neck Squamous Cell Carcinoma
- Being tested
- 89Zr-panitumumab IV, Panitumumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-panitumumab IVDrug
Subjects will be given a bolus of 1.0 mCi (range 0.8 - 1.2 mCi) of 89Zr-panitumumab before undergoing further standard of care diagnostic evaluation of the lesions
PanitumumabDrug
Panitumumab 30mg will be given orally
| Study group | Role | What they receive |
|---|---|---|
| panitumumab 30 mg | Active comparator | Subjects will be given a 30mg of panitumumab Receives: Drug: Panitumumab |
| 89Zr-panitumumab IV | Experimental | Subjects will be given 89Zr-panitumumab IV Receives: Drug: 89Zr-panitumumab IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of 89Zr-panitumumab
The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 89Zr-panitumumab using PET/CT imaging.
Measured: Up to 1 year
Secondary outcomes (1)
Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging
The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 18F-FDG using PET/CT imaging. The specificity and sensitivity of 89Zr-panitumumab will be compared to the specificity and sensitivity of 18F-FDG for identification of metastatic lesions.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: logistical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head-and-neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrei Iagaru
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrei Iagaru, Stanford University
- Investigators
- Fred Baik, MD, Principal investigator, Stanford Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423197
- Sponsor's protocol ID
- IRB-63234
- Other IDs
- ENT0095
- Status last verified
- Aug 2026
- First submitted
- 14 Jun 2022
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05423197
- Acronym / sponsor ID
- IRB-63234
- Conditions
- Head-and-neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: logistical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Andrei IagaruUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 cell carcinoma (HNSCC).
Detailed description
PRIMARY OBJECTIVE(S):
- Determine the sensitivity and specificity of 89Zr-panitumumab for the detection of suspected metastatic lesions
SECONDARY OBJECTIVE(S):
- Compare sensitivity and specificity of 18F-FDG-PET/CT and 89Zr-panitumumab-PET/CT for detection of suspected metastatic lesions
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| panitumumab 30 mg | Active comparator | Drug: PanitumumabSubjects will be given a 30mg of panitumumab |
| 89Zr-panitumumab IV | Experimental | Drug: 89Zr-panitumumab IVSubjects will be given 89Zr-panitumumab IV |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 19 years.
- Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
- Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
- Must have standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions.
- Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results:
Key exclusion criteria (8 listed)
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- History of infusion reactions to other monoclonal antibody therapies
- Pregnant or breastfeeding
- Magnesium or potassium lower than the normal institutional values
- Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-panitumumab IVSubjects will be given a bolus of 1.0 mCi (range 0.8 - 1.2 mCi) of 89Zr-panitumumab before undergoing further standard of care diagnostic evaluation of the lesions | Drug | 89Zr-panitumumab IV |
| PanitumumabPanitumumab 30mg will be given orally | Drug | panitumumab 30 mg |
Primary outcome
Sensitivity and Specificity of 89Zr-panitumumab
Time frame: Up to 1 year
The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 89Zr-panitumumab using PET/CT imaging.
1 secondary outcome
Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Baik, MD principal investigator
Stanford Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 89Zr-panitumumab IV and Panitumumab in people with Head-and-neck Squamous Cell Carcinoma, run by Andrei Iagaru at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of 89Zr-panitumumab (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.