Head and Neck Squamous Cell CarcinomaPhase 1NCT05945875
Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer
A Phase 1 study testing Panitumumab-IRDye800, 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 evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon emission computed tomography (SPECT)/computed tomography (CT) and panitumumab-IRDye800 fluorescence imaging during surgery (intraoperative), to detect disease in… 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-IRDye800, 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 31 Dec 2028
- 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
- Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed
- Planned standard of care elective neck dissection for a cN0 or node- positive disease. Clinical node- positive disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging
- Hemoglobin >= 9 gm/dL
- White blood cell count > 3000/mm^3
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- Platelet count >= 100,000/mm^3
- Serum creatinine =< 1.5 times upper reference range
- Ability to understand and the willingness to sign a written informed consent document
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
- Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
- 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
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- 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
- Thyroid stimulating hormone (TSH) > 13 micro international units/mL
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, 37203
Vanderbilt-Ingram Service Services for Timely Access, 800-811-8480
Eben Rosenthal, MD
About this study
Official title: Official Title Targeted Dual Modality Imaging (TDMI) for Detection and Removal of Head and Neck Cancer
This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon emission computed tomography (SPECT)/computed tomography (CT) and panitumumab-IRDye800 fluorescence imaging during surgery (intraoperative), to detect disease in patients with head and neck cancer. 111In-panitumumab is an imaging agent made of a monoclonal antibody that has been labeled with a radioactive molecule called indium In 111. The agent targets and binds to receptors on tumor cells. This allows the cells to be visualized and assessed with SPECT/CT imaging techniques. SPECT is special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. CT is an imaging technique for examining structures within the body by scanning them with x-rays and using a computer to construct a series of cross-sectional scans along a single axis. Panitumumab-IRDye800 is an imaging agent composed of panitumumab, a monoclonal antibody, linked to a fluorescent dye called IRDye800. Upon administration, panitumumab-IRDye800 targets and binds to receptors on tumor cells. This allows the tumor cells to be detected using fluorescence imaging during surgery. Adding 111In-panitumumab SPECT/CT imaging to intraoperative panitumumab-IRDye800 fluorescence imaging may be more effective at detecting disease in patients with head and neck cancer.
Read the detailed description
Primary Objective:
- Assess the safety of the dual modality imaging (DMI) molecular agents, indium In 111 panitumumab (111In-panitumumab) and panitumumab-IRDye800, in patients with head and neck squamous cell carcinoma (HNSCC).
SECONDARY OBJECTIVES:
- Determine the sensitivity and specificity of 111In-panitumumab and panitumumab-IRDye800 for the detection of subclinical disease during primary tumor removal.
- Determine sensitivity and specificity of 111In-panitumumab and panitumumab-IRDye800 for detection of lymph nodes.
OUTLINE:
Patients receive panitumumab-IRDye800 intravenously (IV) over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging.
After completion of study intervention, patients are followed up at day 15.
- Being tested
- Panitumumab-IRDye800, Indium In 111 Panitumumab, Single Photon Emission Computed Tomography, Computed Tomography, Resection
- 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.
Panitumumab-IRDye800Drug
Given by IV
Indium In 111 PanitumumabOther
Given by IV
Single Photon Emission Computed TomographyProcedure or surgery
Undergo Single Photon Emission Computed Tomography
Computed TomographyProcedure or surgery
Undergo Computed Tomography
ResectionProcedure or surgery
Undergo standard of care surgical resection
Fluorescence ImagingProcedure or surgery
Undergo standard of care fluorescence imaging
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT) | Experimental | Patients receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging. Receives: Drug: Panitumumab-IRDye800; Other: Indium In 111 Panitumumab; Procedure: Single Photon Emission Computed Tomography; Procedure: Computed Tomography; Procedure: Resection; Procedure: Fluorescence Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of grade 2 or higher adverse events
Will assess the number of grade 2 or higher adverse events determined to be significant and definitely or probably related to the study drugs. Adverse events will be evaluated using the Common Terminology Criteria for Adverse Events version 5.0 and summarized by grade, severity, and type.
Measured: Up to day 15
Secondary outcomes (4)
Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved margins
Detection of a positive margin defined as 1) presence of tumor within 5 mm of the cut surface of the specimen by using fluorescence imaging and 2) residual tumor present after removal of primary specimen by using fluorescence imaging and nuclear (gamma) signal in the wound bed. Findings will be compared to final histopathology as a reference standard. Presence of positive margin and residual tumor in the wound bed will be analyzed separately. Will calculate sensitivity with its 95% confidence interval. Will further perform McNemar's agreement test to examine whether there is any evidence of disagreement between these two sets of results.
Measured: Up to 4 years
Specificity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved margins
Detection of a positive margin defined as 1) presence of tumor within 5 mm of the cut surface of the specimen by using fluorescence imaging and 2) residual tumor present after removal of primary specimen by using fluorescence imaging and nuclear (gamma) signal in the wound bed. Findings will be compared to final histopathology as a reference standard. Presence of positive margin and residual tumor in the wound bed will be analyzed separately. Will calculate specificity with its 95% confidence interval. Will further perform McNemar's agreement test to examine whether there is any evidence of disagreement between these two sets of results.
Measured: Up to 4 years
Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes
Intraoperatively, the number and location of tumor-positive lymph nodes will be determined using gamma signal and fluorescence imaging in the same format that surgeons have used during sentinel node mapping. Will perform near infrared fluorescence imaging and determine if these fluorescent lymph node(s) contain 111In-panitumumab via gamma tracing. All lymph nodes will be compared to gold standard histopathology for presence of disease.
Measured: Up to 4 years
Specificity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes
Intraoperatively, the number and location of tumor-positive lymph nodes will be determined using gamma signal and fluorescence imaging in the same format that surgeons have used during sentinel node mapping. Will perform near infrared fluorescence imaging and determine if these fluorescent lymph node(s) contain 111In-panitumumab via gamma tracing. All lymph nodes will be compared to gold standard histopathology for presence of disease.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start3 Oct 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- 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
- NCT05945875
- Sponsor's protocol ID
- VICC-EDHAN23204P
- Other IDs
- NCI-2023-05124, 1R01CA266233-01A1
- Status last verified
- Sep 2025
- First submitted
- 6 Jul 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Burns CR, Mattingly AS, Ely K, Radevic A, Meeks N, Zaidi SMA, Brown B, Vasiukov G, Topf M, Rosenthal E. Intraoperative Molecular Imaging Can Detect Large Nerve Perineural Invasion: A Case Report. Head Neck. 2026 Jun;48(6):E58-E61. doi: 10.1002/hed.70160. Epub 2026 Jan 7.
PubMed 41498537
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Official Title Targeted Dual Modality Imaging (TDMI) for Detection and Removal of Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05945875
- Acronym / sponsor ID
- VICC-EDHAN23204P
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Jul 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 evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon emission computed tomography (SPECT)/computed tomography (CT) and panitumumab-IRDye800 fluorescence imaging during surgery (intraoperative), to detect disease in patients with head and neck cancer. 111In-panitumumab is an imaging agent made of a monoclonal antibody that has been labeled with a radioactive molecule called indium In 111. The agent targets and binds to receptors on tumor cells. This allows the cells to be visualized and assessed with SPECT/CT imaging techniques. SPECT is special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. CT is an imaging technique for examining structures within the body by scanning them with x-rays and using a computer to construct a series of cross-sectional scans along a single axis. Panitumumab-IRDye800 is an imaging agent composed of panitumumab, a monoclonal antibody, linked to a fluorescent dye called IRDye800. Upon administration, panitumumab-IRDye800 targets and binds to receptors on tumor cells. This allows the tumor cells to be detected using fluorescence imaging during surgery. Adding 111In-panitumumab SPECT/CT imaging to intraoperative panitumumab-IRDye800 fluorescence imaging may be more effective at detecting disease in patients with head and neck cancer.
Detailed description
Primary Objective:
- Assess the safety of the dual modality imaging (DMI) molecular agents, indium In 111 panitumumab (111In-panitumumab) and panitumumab-IRDye800, in patients with head and neck squamous cell carcinoma (HNSCC).
SECONDARY OBJECTIVES:
- Determine the sensitivity and specificity of 111In-panitumumab and panitumumab-IRDye800 for the detection of subclinical disease during primary tumor removal.
- Determine sensitivity and specificity of 111In-panitumumab and panitumumab-IRDye800 for detection of lymph nodes.
OUTLINE:
Patients receive panitumumab-IRDye800 intravenously (IV) over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging.
After completion of study intervention, patients are followed up at day 15.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT) | Experimental | Drug: Panitumumab-IRDye800, Other: Indium In 111 Panitumumab, Procedure: Single Photon Emission Computed Tomography, Procedure: Computed Tomography, Procedure: Resection, Procedure: Fluorescence ImagingPatients receive panitumumab-IRDye800 IV over 15 minutes followed by 111In-panitumumab IV on day 0. Patients then undergo SPECT/CT between days 1 and 5, prior to standard of care surgical resection with fluorescence imaging. |
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
- Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed
- Planned standard of care elective neck dissection for a cN0 or node- positive disease. Clinical node- positive disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging
- Hemoglobin >= 9 gm/dL
Key exclusion criteria (10 listed)
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- Evidence of QT prolongation on pretreatment electrocardiogram (ECG) (greater than 440 ms in males or greater than 450 ms in females)
- History of infusion reactions to monoclonal antibody therapies
- History of allergies to iodine
- Pregnant or breastfeeding
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 |
|---|---|---|
| Panitumumab-IRDye800Given by IV | Drug | Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT) |
| Indium In 111 PanitumumabGiven by IV | Other | Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT) |
| Single Photon Emission Computed TomographyUndergo Single Photon Emission Computed Tomography | Procedure or surgery | Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT) |
| Computed TomographyUndergo Computed Tomography | Procedure or surgery | Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT) |
| ResectionUndergo standard of care surgical resection | Procedure or surgery | Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT) |
| Fluorescence ImagingUndergo standard of care fluorescence imaging | Procedure or surgery | Diagnostic (panitumumab-IRDye800, 111In-panitumumab, SPECT/CT) |
Primary outcome
Number of grade 2 or higher adverse events
Time frame: Up to day 15
Will assess the number of grade 2 or higher adverse events determined to be significant and definitely or probably related to the study drugs. Adverse events will be evaluated using the Common Terminology Criteria for Adverse Events version 5.0 and summarized by grade, severity, and type.
4 secondary outcomes
Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved margins
Time frame: Up to 4 years
Specificity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved margins
Time frame: Up to 4 years
Sensitivity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes
Time frame: Up to 4 years
Specificity of 111In-panitumumab and panitumumab-IRDy800 for the detection of tumor-involved lymph nodes
Time frame: Up to 4 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 3 Oct 2025.
- Derived from this study: PubMed 41498537Burns CR, Mattingly AS, Ely K, Radevic A, Meeks N, Zaidi SMA, Brown B, Vasiukov G, Topf M, Rosenthal E. Intraoperative Molecular Imaging Can Detect Large Nerve Perineural Invasion: A Case Report. Head Neck. 2026 Jun;48(6):E58-E61. doi: 10.1002/hed.70160. Epub 2026 Jan 7.
- Individual participant dataSharing planned: Undecided
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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.
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-IRDye800, 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 10 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 3 Oct 2025. 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?
Number of grade 2 or higher adverse events (time frame: Up to day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05945875, which also lists 1 linked publication.
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 3 Oct 2025.