Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Location contact
Kyrionna Golliday
CONTACT
Michael Topf, MD
PRINCIPAL_INVESTIGATOR
Nicole Jones
CONTACT
NCT Number: NCT06915454
Imaging will be exploratory and be used intraoperatively. There have been no discovered risks associated with the device to be used in this study, and none are anticipated given the diagnostic and non-invasive, 'ex vivo' nature of device use. Of note, the surgical resection will proceed as per standard of care and will not be affected by the research protocol.
Potential Benefit: Imaging intra-operatively will ensure surgeons to identify at risk resection margins.
Time Commitment: There are no additional visits that will be asked of you to partake in this study.
Drug is FDA approved and Exposure to Radiation is minimal.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
Location status: Recruiting
Kyrionna Golliday
CONTACT
Michael Topf, MD
PRINCIPAL_INVESTIGATOR
Nicole Jones
CONTACT
This pilot study explores the use of high-resolution PET imaging to identify surgical margins in solid tumors after removal. It evaluates the feasibility and potential of using PET-CT to assess tumor specimens and ensures radiation safety with a low-dose 18-FDG injection (20% of the standard dose). Previous studies have shown good tumor visualization in breast, pancreatic, prostate, and head and neck tumors, supporting the method's proof-of-concept. This research aims to gather insights into its clinical usefulness across different cases
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Once the tumor or cancer is resected, it will then be imaged with the XEOS Aura 10 PET/CT Imaging Device. Imaging will be obtained utilizing a XEOS AURA 10 scanner in real time while in the operating room with the surgery team still present.
Other names: XEOS Aura 10
Time frame: Day of Surgery.
This study is an exploratory pilot study where the main goal is to gather scientific knowledge. Since no results with a certain significance need to be proven, no power analysis will be performed.
Pre-Surgery Preparation: Patients are injected with a PET (18F-FDG) tracer. This tracer highlights cancerous tissues by emitting signals detectable by PET imaging.
Intraoperative Imaging: Once the tumor is removed, the specimen is scanned using the XEOS Aura 10 device in the operating room. This allows surgeons to get detailed images of the tumor and surrounding tissues.
Immediate Analysis: The imaging provides real-time feedback on the tumor's characteristics, such as margins and whether all cancerous tissue has been removed. This can help surgeons make decisions during the operation, like whether additional tissue needs to be excised.
Comparison with Pathology: The PET-CT images are later compared with traditional pathology results to validate their accuracy and usefulness.
Time frame: Day of Surgery to Pathology
Researchers will compare pathology data that is to be completed as standard of care to the XEOS Aura 10 specimen scanner margins.
Time frame: Day of Surgery to Pathology
Researchers will compare pathology data that is to be completed as standard of care to the XEOS Aura 10 specimen scanner margins.
Time frame: Day of Surgery to 10 days.
Researchers will compare standard of care imaging data to the XEOS Aura 10 specimen scanner data.
Contact information is provided by the study sponsor or research team.
Kyrionna Golliday
CONTACT
Nicole Jones
CONTACT
Vanderbilt-Ingram Cancer Center
Other
High-resolution Specimen PET-CT Imaging for the Intraoperative Visualization of Resection Margins: an Exploratory Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03993353
Cancer, Cancer of Esophagus
La Jolla, California, United States
View Trial DetailsNCT03383094
Cancer, Cancer of Head and Neck
Tucson, Arizona, United States
View Trial DetailsNCT04485013
Adenocarcinoma, Adenocarcinoma of Lung
Tucson, Arizona, United States
View Trial DetailsNCT06682793
Adenocarcinoma, Breast Diseases
Gilbert, Arizona, United States
View Trial Details