NCT04266470

Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region

Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region Using the Lara Device

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the ability of Lucerno Dynamics Lara sensor when placed on the palpable carotid artery (or femoral artery) to monitor blood flow following the injection of 18-FDG and to distinguish peak flow in tumor versus tissue uptake. Investigators will then assess if differences in tumor versus tissue correlates with tumor response.

Detailed description

Primary Objective: To determine if Lara sensors placed over the carotid and femoral arteries can measure the plasma activity of 18 F-fludeoxyglucose (18-FDG) at time of injection and determine if that peak activity in the artery can be distinguished from peak activity in malignant tissue to provide enough information to obtain the arterial input function. Secondary Objective: To evaluate changes (baseline to post treatment) in tissue uptake at first pass (AUC and time to peak blood flow) and during the 60-minute period (metabolic activity) leading to the , positron emission tomography (PET) scan. This data is to be collected from the Lucerno Device placed over the carotid and femoral arteries monitoring 18 F-fludeoxyglucose (18-FDG) activity in blood and malignant tissue throughout the pre positron emission tomography (PET) scan period.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DEVICE	Lara Scan	Four (4) sensors will be placed prior to the injection of 18 F-fludeoxyglucose (18FDG) at the following sites: 7 cm above injection site; injection site; surface of palpable presumed malignant tissue; palpable carotid artery. Standard doses of 18-FDG will be injected per Department of Radiology protocols All injections will be evaluated to insure the total dose of 18-FDG has been injected. Injections resulting in moderate to severe extravasations, as interpreted by Lara software, will be segregated and evaluated on an individual basis. The sensors will remain in place for 60 minutes during the 18-FDG uptake period with the patient in a reclined chair. After the uptake time is complete, the sensors will be removed by the technologist and the participant will be released. The study team will then upload the sensor data to a personal computer in the treatment planning room where it will be coded and processed as a Lara scan.
DIAGNOSTIC_TEST	PET/CT Scan - Pre-treatment and Post-treatment	The PET/CT imaging will be conducted according to standard of care. The main alteration to process flow will be the addition of the Lucerno sensors just prior to the injection of the PET material.

Timeline

• Start date: 2020-03-09
• Primary completion: 2022-03-10
• Completion: 2022-03-10
• First posted: 2020-02-12
• Last updated: 2022-03-29

Regulatory

• FDA-regulated device study