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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Withdrawn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
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 10, 2020
    Last Updated
    March 11, 2022
    Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)
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    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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