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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-05124 | Registry Identifier | NCI, Clinical Trials Reporting Program | |
| 1R01CA266233-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab-IRDye800 | Drug | Given by IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Jones | Contact | 615-936-2807 | nicole.l.jones@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Eben Rosenthal, MD | Vanderbilt University/Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University/Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41498537 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2025 | Sep 29, 2025 |
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| Indium In 111 Panitumumab |
| Other |
Given by IV |
|
| Single Photon Emission Computed Tomography | Procedure | Undergo Single Photon Emission Computed Tomography |
|
| Computed Tomography | Procedure | Undergo Computed Tomography |
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| Resection | Procedure | Undergo standard of care surgical resection |
|
| Fluorescence Imaging | Procedure | Undergo standard of care fluorescence imaging |
|
| 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. | 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. | 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. | Up to 4 years |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D007204 | Indium |
| D061848 | Optical Imaging |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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