Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region
Primary Purpose
Squamous Cell Carcinoma of Head and Neck
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lara Scan
PET/CT Scan - Pre-treatment and Post-treatment
Sponsored by
About this trial
This is an interventional device feasibility trial for Squamous Cell Carcinoma of Head and Neck focused on measuring Monitoring blood flow, Metabolic activity in malignant tissue - head/ neck, Tumor response to therapy
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lara Device Scan
Arm Description
This imaging study will be obtained strictly for the research purposes of mid-treatment assessment of blood flow and uptake kinetics analysis
Outcomes
Primary Outcome Measures
Percentage of Tests That Input Function (IF) Could Be Calculated
If input function can be calculated on five (5) or more (out of 10) patients, then investigators will consider this a feasible procedure. Input function is calculated using time-activity curves (TAC) from the arterial blood flow detector and integrating the signal over time. Peak and minimum values of each of the four (4) Lara detector time-activity curves (TAC) will be recorded to determine a range of expected values and if they are different.
Secondary Outcome Measures
Change in Areas Under the Curve (AUC) Measurements
Investigators will use a repeated measures linear model with change in areas under the curve as the outcome and time from baseline and the baseline area under the curve as predictors. From the model investigators will report the estimated change at the post treatment Lara measurement. Participants should have three measurements of area under the curve (baseline, mid-treatment, 3-week measurement prior to PET scan).
Change in Time to Peak Arterial Blood Flow
Investigators will use a repeated measures linear model with change in areas under the curve as the outcome and time from baseline and the baseline area under the curve as predictors. From the model investigators will report the estimated change at the post treatment Lara measurement. Participants should have three measurements of area under the curve (baseline, mid-treatment, 3-week measurement prior to PET scan).
Full Information
NCT ID
NCT04266470
First Posted
February 10, 2020
Last Updated
March 11, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04266470
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study is no longer feasible at our site.
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
March 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Head and Neck
Keywords
Monitoring blood flow, Metabolic activity in malignant tissue - head/ neck, Tumor response to therapy
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lara Device Scan
Arm Type
Experimental
Arm Description
This imaging study will be obtained strictly for the research purposes of mid-treatment assessment of blood flow and uptake kinetics analysis
Intervention Type
Device
Intervention Name(s)
Lara Scan
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT Scan - Pre-treatment and Post-treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Tests That Input Function (IF) Could Be Calculated
Description
If input function can be calculated on five (5) or more (out of 10) patients, then investigators will consider this a feasible procedure. Input function is calculated using time-activity curves (TAC) from the arterial blood flow detector and integrating the signal over time. Peak and minimum values of each of the four (4) Lara detector time-activity curves (TAC) will be recorded to determine a range of expected values and if they are different.
Time Frame
At baseline
Secondary Outcome Measure Information:
Title
Change in Areas Under the Curve (AUC) Measurements
Description
Investigators will use a repeated measures linear model with change in areas under the curve as the outcome and time from baseline and the baseline area under the curve as predictors. From the model investigators will report the estimated change at the post treatment Lara measurement. Participants should have three measurements of area under the curve (baseline, mid-treatment, 3-week measurement prior to PET scan).
Time Frame
Baseline up to 120 days after completion of treatment
Title
Change in Time to Peak Arterial Blood Flow
Description
Investigators will use a repeated measures linear model with change in areas under the curve as the outcome and time from baseline and the baseline area under the curve as predictors. From the model investigators will report the estimated change at the post treatment Lara measurement. Participants should have three measurements of area under the curve (baseline, mid-treatment, 3-week measurement prior to PET scan).
Time Frame
Baseline up to 120 days after completion of treatment
Other Pre-specified Outcome Measures:
Title
Tumor Response
Description
A correlation will be calculated between areas under change and percent change in tumor size.
Time Frame
Baseline and 120 days after completion of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Frizzell, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region
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