Head and Neck Squamous Cell CarcinomaPhase 1NCT05901545
Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer
A Phase 1 study testing Panitumumab, Indium In 111 Panitumumab and Single Photon Emission Computed Tomography in people with Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. 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, Recurrent Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Panitumumab, Indium In 111 Panitumumab and Single Photon Emission Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2023to 30 Nov 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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, clinically-staged as node-negative (cN0) or as clinically-suspicious node(s).
- Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
- Planned standard of care elective neck dissection for node-negative or node-positive disease.
- Have acceptable hematologic status, kidney function, and liver function including the following clinical results:
- Hemoglobin ≥ 9 gm/dL
Show all 9Show fewer
- White blood cell count > 3000/mm^3
- Platelet count ≥ 100,000/mm^3
- Serum creatinine ≤ 1.5 times upper reference range
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 monoclonal antibody therapies
- History of allergies to iodine
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Vanderbilt-Ingram Service Services for Timely Access, 800-811-8480, cip@vumc.org
Eben Rosenthal, MD
About this study
This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography/computed tomography (SPECT/CT). SPECT/CT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.
Read the detailed description
PRIMARY OBJECTIVE:
- Assess the safety of indium In 111 panitumumab (111In-panitumumab) as a molecular imaging agent in patients with HNSCC.
SECONDARY OBJECTIVE:
- Compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to day of surgery versus conventional local injection with an optical dye at the time of surgery.
EXPLORATORY OBJECTIVES:
- Determine if systemic injection of 111In-panitumumab can identify tumor-positive lymph nodes on preoperative SPECT/CT.
II. When preoperative imaging information (eg, fludeoxyglucose F 18 [18F-FDG] positron emission tomography [PET]/CT and/or magnetic resonance imaging [MRI]) data is available:
IIa. Evaluate the sensitivity, specificity, and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity, and negative predictive value of preoperative MRI in identifying metastatic lymph nodes (histopathological results will serve as the gold standard).
IIb. Evaluate the sensitivity, specificity, and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity, and negative predictive value of preoperative 18F-FDG PET/CT in identifying metastatic lymph nodes (histopathological results will serve as the gold standard).
OUTLINE:
Patients receive loading dose of panitumumab intravenously (IV) over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and near infrared (NIR) imaging. Patients additionally undergo blood sample collection during screening and electrocardiography (ECG) during screening, on day 0, and on day 15 if indicated.
Patients are followed for up to 15 days after last dose of study medication.
- Being tested
- Panitumumab, Indium In 111 Panitumumab, Single Photon Emission Computed Tomography, Computed Tomography, Surgical Procedure
- 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.
PanitumumabBiological
Given by IV
Indium In 111 PanitumumabOther
Given by IV
Single Photon Emission Computed TomographyProcedure or surgery
Undergo SPECT/CT
Computed TomographyProcedure or surgery
Undergo SPECT/CT
Surgical ProcedureProcedure or surgery
Undergo standard of care surgery
Imaging agentOther
Receive local injection of optical dye
Intraoperative ImagingProcedure or surgery
Undergo Intraoperative Imaging
Near Infrared ImagingProcedure or surgery
Undergo Near Infrared Imaging
ElectrocardiographyProcedure or surgery
Undergo Electrocardiography
Biospecimen CollectionProcedure or surgery
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) | Experimental | Patients receive loading dose of panitumumab IV over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated. Receives: Biological: Panitumumab; Other: Indium In 111 Panitumumab; Procedure: Single Photon Emission Computed Tomography; Procedure: Computed Tomography; Procedure: Surgical Procedure; Other: Imaging agent; Procedure: Intraoperative Imaging; Procedure: Near Infrared Imaging; Procedure: Electrocardiography; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events grade 2 or higher
Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Summarized by grade, severity and type
Measured: Up to 15 days after administration of study drug
Secondary outcomes (2)
Sensitivity of systemic injection of indium In 111 panitumumab (111In-panitumumab) for identifying sentinel lymph nodes
Will compare the sensitivity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes to the sensitivity of conventional local injection with an optical dye at the time of surgery. Means and standard deviations for continuous characteristics will be presented. Frequency statistics will be presented for categorical variables. Graphical tools may be used to assess distributional properties of continuous variables.
Measured: Up to five years
Specificity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes
Will compare the specificity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes to the sensitivity of conventional local injection with an optical dye at the time of surgery. Means and standard deviations for continuous characteristics will be presented. Frequency statistics will be presented for categorical variables. Graphical tools may be used to assess distributional properties of continuous variables.
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start22 Aug 2023
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Eben Rosenthal, Vanderbilt-Ingram Cancer Center
- Investigators
- Eben Rosenthal, MD, Principal investigator, Vanderbilt University/Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901545
- Sponsor's protocol ID
- VICC-EDHAN23201P
- Other IDs
- NCI-2023-03821
- Status last verified
- Feb 2026
- First submitted
- 4 Jun 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05901545
- Acronym / sponsor ID
- VICC-EDHAN23201P
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 13 Jun 2023 (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.
This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography/computed tomography (SPECT/CT). SPECT/CT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.
Detailed description
PRIMARY OBJECTIVE:
- Assess the safety of indium In 111 panitumumab (111In-panitumumab) as a molecular imaging agent in patients with HNSCC.
SECONDARY OBJECTIVE:
- Compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to day of surgery versus conventional local injection with an optical dye at the time of surgery.
EXPLORATORY OBJECTIVES:
- Determine if systemic injection of 111In-panitumumab can identify tumor-positive lymph nodes on preoperative SPECT/CT.
II. When preoperative imaging information (eg, fludeoxyglucose F 18 [18F-FDG] positron emission tomography [PET]/CT and/or magnetic resonance imaging [MRI]) data is available:
IIa. Evaluate the sensitivity, specificity, and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity, and negative predictive value of preoperative MRI in identifying metastatic lymph nodes (histopathological results will serve as the gold standard).
IIb. Evaluate the sensitivity, specificity, and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity, and negative predictive value of preoperative 18F-FDG PET/CT in identifying metastatic lymph nodes (histopathological results will serve as the gold standard).
OUTLINE:
Patients receive loading dose of panitumumab intravenously (IV) over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and near infrared (NIR) imaging. Patients additionally undergo blood sample collection during screening and electrocardiography (ECG) during screening, on day 0, and on day 15 if indicated.
Patients are followed for up to 15 days after last dose of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) | Experimental | Biological: Panitumumab, Other: Indium In 111 Panitumumab, Procedure: Single Photon Emission Computed Tomography, Procedure: Computed Tomography, Procedure: Surgical Procedure, Other: Imaging agent, Procedure: Intraoperative Imaging, Procedure: Near Infrared Imaging, Procedure: Electrocardiography, Procedure: Biospecimen CollectionPatients receive loading dose of panitumumab IV over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 19 years.
- Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck, clinically-staged as node-negative (cN0) or as clinically-suspicious node(s).
- Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
- Planned standard of care elective neck dissection for node-negative or node-positive disease.
- Have acceptable hematologic 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 monoclonal antibody therapies
- History of allergies to iodine
- Pregnant or breastfeeding.
- Magnesium or potassium lower than the normal institutional values.
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 |
|---|---|---|
| PanitumumabGiven by IV | Biological | Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) |
| Indium In 111 PanitumumabGiven by IV | Other | Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) |
| Single Photon Emission Computed TomographyUndergo SPECT/CT | Procedure or surgery | Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) |
| Computed TomographyUndergo SPECT/CT | Procedure or surgery | Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) |
| Surgical ProcedureUndergo standard of care surgery | Procedure or surgery | Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) |
| Imaging agentReceive local injection of optical dye | Other | Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) |
| Intraoperative ImagingUndergo Intraoperative Imaging | Procedure or surgery | Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) |
| Near Infrared ImagingUndergo Near Infrared Imaging | Procedure or surgery | Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) |
| ElectrocardiographyUndergo Electrocardiography | Procedure or surgery | Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) |
| Biospecimen CollectionUndergo blood sample collection | Procedure or surgery | Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery) |
Primary outcome
Incidence of adverse events grade 2 or higher
Time frame: Up to 15 days after administration of study drug
Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Summarized by grade, severity and type
2 secondary outcomes
Sensitivity of systemic injection of indium In 111 panitumumab (111In-panitumumab) for identifying sentinel lymph nodes
Time frame: Up to five years
Specificity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes
Time frame: Up to five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruiting
Tumoral Versus Luminal Microbiome in Head and Neck Squamous Cell Carcinoma
Squamous Cell Cancer of Head and Neck (SCCHN)
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.
Eben Rosenthal, MD principal investigator
Vanderbilt University/Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Panitumumab, Indium In 111 Panitumumab and Single Photon Emission Computed Tomography in people with Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, run by Vanderbilt-Ingram Cancer Center 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 9 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: looking for participants now, as of the sponsor's last update on 5 Mar 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Jones (615-936-2807, nicole.l.jones@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events grade 2 or higher (time frame: Up to 15 days after administration of study drug). 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 5 Mar 2026.