Clinical trial NCT04266470: Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region
Official title: Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region Using the Lara Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: Monitoring blood flow
Metabolic activity in malignant tissue - head/ neck
Tumor response to therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-02-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Eligibility 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

Primary outcomes:
measure: Percentage of Tests That Input Function (IF) Could Be Calculated
timeFrame: At baseline
Secondary outcomes:
measure: Change in Areas Under the Curve (AUC) Measurements
timeFrame: Baseline up to 120 days after completion of treatment
measure: Change in Time to Peak Arterial Blood Flow
timeFrame: Baseline up to 120 days after completion of treatment
Other outcomes:
measure: Tumor Response
timeFrame: Baseline and 120 days after completion of treatment
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Bart Frizzell, MD
role: PRINCIPAL_INVESTIGATOR
References: