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

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Squamous Cell Carcinoma of Head and Neck

Treatments: Diagnostic Test: PET/CT Scan - Pre-treatment and Post-treatment; Device: Lara Scan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04266470

IRB00056907

P30CA012197 (U.S. NIH Grant/Contract)

WFBCCC 01919 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Squamous cell carcinoma of the nasopharynx, oral cavity, oropharynx or hypopharynx with palpable adenopathy in the neck. Biopsy proven within the last 90 days.
• Squamous cell carcinoma of the larynx regardless of lymph node status. Biopsy proven within the last 90 days.
• Age 18 or greater.
• Receiving definitive radiation therapy at Wake Forest University with or without concurrent systematic therapy.
• Participants must be able to provide study specific informed consent prior to study entry.
• Presence of metastatic disease is not an exclusion criteria provided subject will be receiving definitive doses of radiation to the local and regional disease.

Exclusion Criteria

• Cancers of the head and neck other than those stated above. This would include squamous cell carcinoma of unknown primary.
• No measurable disease in the head and neck (ie planned adjuvant radiation therapy for allowable cancers with high risk pathology following definitive surgery).
• Persons receiving less than curative doses of radiation.
• Age under 18
• Unable or unwilling to tolerate PET/CT scan
• Unable or unwilling to receive definitive treatment of their cancer at Wake Forest University
• Pregnant women
• Participants who present having already undergone a PET/CT will not be eligible for this study-because an important element of this trial is the assessment of 18-FDG uptake changes in response to treatment

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Lara Device Scan

Experimental group

Description:

This imaging study will be obtained strictly for the research purposes of mid-treatment assessment of blood flow and uptake kinetics analysis

Treatment:

Device: Lara Scan

Diagnostic Test: PET/CT Scan - Pre-treatment and Post-treatment