Ignite Creation Date:
2024-05-06 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945875
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-07-06
Brief Title:
Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Official Title Targeted Dual Modality Imaging TDMI for Detection and Removal of Head and Neck Cancer
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 SPECTcomputed 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 SPECTCT 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 SPECTCT 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 SPECTCT 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
- 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 SPECTCT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-05124 | REGISTRY | None | None |
| 1R01CA266233-01A1 | NIH | NCI Clinical Trials Reporting Program | httpsreporternihgovquickSearch1R01CA266233-01A1 |