Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients with Head and Neck Cancer
Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients with 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.
Phase I
Phase I
Adults
Not Available
Not Available
Rosenthal, Eben
Local
Vanderbilt University
10-03-2023
Eligibility
19 Years and older
ALL
false
Inclusion Criteria:
Age >= 19 years
Age >= 19 years
Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
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
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
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
Hemoglobin >= 9 gm/dL
White blood cell count > 3000/mm\^3
White blood cell count > 3000/mm\^3
Platelet count >= 100,000/mm\^3
Platelet count >= 100,000/mm\^3
Serum creatinine = 1.5 times upper reference range
Serum creatinine = 1.5 times upper reference range
Ability to understand and the willingness to sign a written informed consent document
Ability to understand and the willingness to sign a written informed consent document
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
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)
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 infusion reactions to monoclonal antibody therapies
History of allergies to iodine
History of allergies to iodine
Pregnant or breastfeeding
Pregnant or breastfeeding
Magnesium or potassium lower than the normal institutional values
Magnesium or potassium lower than the normal institutional values
Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
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
Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
Severe renal disease or anuria
Severe renal disease or anuria
Thyroid stimulating hormone (TSH) > 13 micro international units/mL
Thyroid stimulating hormone (TSH) > 13 micro international units/mL
Age >= 19 years
Age >= 19 years
Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
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
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
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
Hemoglobin >= 9 gm/dL
White blood cell count > 3000/mm\^3
White blood cell count > 3000/mm\^3
Platelet count >= 100,000/mm\^3
Platelet count >= 100,000/mm\^3
Serum creatinine = 1.5 times upper reference range
Serum creatinine = 1.5 times upper reference range
Ability to understand and the willingness to sign a written informed consent document
Ability to understand and the willingness to sign a written informed consent document
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
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)
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 infusion reactions to monoclonal antibody therapies
History of allergies to iodine
History of allergies to iodine
Pregnant or breastfeeding
Pregnant or breastfeeding
Magnesium or potassium lower than the normal institutional values
Magnesium or potassium lower than the normal institutional values
Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
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
Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
Severe renal disease or anuria
Severe renal disease or anuria
Thyroid stimulating hormone (TSH) > 13 micro international units/mL
Thyroid stimulating hormone (TSH) > 13 micro international units/mL
