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WithdrawnNCT05423197Updated Aug 17, 2026

89Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in HNSCC

A Phase 2 interventional study of 89Zr-panitumumab IV and Panitumumab in Head-and-neck Squamous Cell Carcinoma, sponsored by Andrei Iagaru. Withdrawn at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Andrei Iagaru · Phase 2, Interventional, and Diagnostic

Why this study was withdrawn
logistical issues
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Head-and-neck Squamous Cell Carcinoma
03

In context

Squamous Cell Carcinoma of Head and Neck

2,018 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

Andrei Iagaru is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 19 years.
  • 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 lesions.
  • Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results:

    • ≥ 9gm/dL
    • White blood cell count > 3000/mm3
    • count ≥ 100,000/mm3
    • Serum creatinine ≤ 1.5 times upper reference range
    • = 11.5 - 14.4 seconds
    • INR = 0.9 - 1.2

Exclusion criteria

Exclusion Criteria:

  • 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 to deferoxamine or any of its components
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    panitumumab 30 mg

    Subjects will be given a 30mg of panitumumab

    Drug: Panitumumab

  • Experimental
    89Zr-panitumumab IV

    Subjects will be given 89Zr-panitumumab IV

    Drug: 89Zr-panitumumab IV

Interventions

  • Drug89Zr-panitumumab IV

    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

  • Panitumumab 30mg will be given orally

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Up to 1 year

07

Study locations

1 site
  • Stanford Cancer Institute
    San Francisco, California 94305, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05423197
Lead sponsor
Andrei Iagaru
Responsible party
Andrei Iagaru (Professor of Radiology (Nuclear Medicine), Stanford University) — Sponsor-investigator
First posted
Jun 21, 2022
Start date
Jun 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 17, 2026

Study contacts

Fred Baik, MD
principal investigator · Stanford Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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