NCT05945875 Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer
| NCT ID | NCT05945875 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Vanderbilt-Ingram Cancer Center |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-10-03 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2023-10-03 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 * 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 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 * 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 * 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
Contact & Investigator
Eben Rosenthal, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University/Ingram Cancer Center
Frequently Asked Questions
Who can join the NCT05945875 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05945875 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05945875 currently recruiting?
Yes, NCT05945875 is actively recruiting participants. Contact the research team at nicole.l.jones@vumc.org for enrollment information.
Where is the NCT05945875 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05945875 clinical trial?
NCT05945875 is sponsored by Vanderbilt-Ingram Cancer Center. The principal investigator is Eben Rosenthal, MD at Vanderbilt University/Ingram Cancer Center. The trial plans to enroll 40 participants.