Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Panitumumab

Antineoplastic Agents, Immunological

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.

Indium In 111 Panitumumab

Single Photon Emission Computed Tomography

Computed Tomography

Surgical Procedure

Imaging agent

Intraoperative Imaging

Near Infrared Imaging

Electrocardiography

Biospecimen Collection

Vanderbilt-Ingram Services for Timely Access

Vanderbilt-Ingram Service Services for Timely Access

Eben Rosenthal, MD

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.

PRIMARY OBJECTIVE:

I. Assess the safety of indium In 111 panitumumab (111In-panitumumab) as a molecular imaging agent in patients with HNSCC.

SECONDARY OBJECTIVE:

I. 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:

I. 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.

Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer

Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Summarized by grade, severity and type

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.

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.

American Cancer Society, Inc.

Vanderbilt-Ingram Cancer Center

Professor of Medicine

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.

Panitumumab-IRDye800

Undergo Single Photon Emission Computed Tomography

Undergo standard of care surgical resection

Resection

Undergo standard of care fluorescence imaging

Fluorescence Imaging

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:

* 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.

Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer

Official Title Targeted Dual Modality Imaging (TDMI) for Detection and Removal of Head and Neck Cancer

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer	NCT05901545	Head and Neck S... Recurrent Head ...	Panitumumab Indium In 111 P... Single Photon E... Computed Tomogr... Surgical Proced... Imaging agent Intraoperative ... Near Infrared I... Electrocardiogr... Biospecimen Col...	19 Years -	Vanderbilt-Ingram Cancer Center
Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer	NCT05945875	Head and Neck S... Recurrent Head ...	Panitumumab-IRD... Indium In 111 P... Single Photon E... Computed Tomogr... Resection Fluorescence Im...	19 Years -	Vanderbilt-Ingram Cancer Center

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