Squamous Cell Carcinoma of Head and NeckNCT04266470
Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region
A study testing Lara Scan and PET/CT Scan - Pre-treatment and Post-treatment in people with Squamous Cell Carcinoma of Head and Neck, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Lara Scan and PET/CT Scan - Pre-treatment and Post-treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2020to 10 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region Using the Lara Device
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.
Read the 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
- Being tested
- Lara Scan, PET/CT Scan - Pre-treatment and Post-treatment
- Keywords
- Monitoring blood flow, Metabolic activity in malignant tissue - head/ neck, Tumor response to therapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lara ScanDevice
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.
PET/CT Scan - Pre-treatment and Post-treatmentDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Lara Device Scan | Experimental | This imaging study will be obtained strictly for the research purposes of mid-treatment assessment of blood flow and uptake kinetics analysis Receives: Device: Lara Scan; Diagnostic Test: PET/CT Scan - Pre-treatment and Post-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (2)
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).
Measured: Baseline up to 120 days after completion of treatment
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).
Measured: Baseline up to 120 days after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start9 Mar 2020
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Why it stopped: Study is no longer feasible at our site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bart Frizzell, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266470
- Sponsor's protocol ID
- IRB00056907
- Other IDs
- P30CA012197, WFBCCC 01919
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Blood Flow and Metabolic Activity in Malignant Tissue of Head and Neck Region Using the Lara Device
- ClinicalTrials.gov ID
- NCT04266470
- Acronym / sponsor ID
- IRB00056907
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- Monitoring blood flow, Metabolic activity in malignant tissue - head/ neck, Tumor response to therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study is no longer feasible at our site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lara Device Scan | Experimental | Device: Lara Scan, Diagnostic Test: PET/CT Scan - Pre-treatment and Post-treatmentThis imaging study will be obtained strictly for the research purposes of mid-treatment assessment of blood flow and uptake kinetics analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lara ScanFour (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. | Device | Lara Device Scan |
| PET/CT Scan - Pre-treatment and Post-treatmentThe 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. | Diagnostic test | Lara Device Scan |
Primary outcome
Percentage of Tests That Input Function (IF) Could Be Calculated
Time frame: At baseline
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.
2 secondary outcomes
Change in Areas Under the Curve (AUC) Measurements
Time frame: Baseline up to 120 days after completion of treatment
Change in Time to Peak Arterial Blood Flow
Time frame: Baseline up to 120 days after completion of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Frizzell, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Lara Scan and PET/CT Scan - Pre-treatment and Post-treatment in people with Squamous Cell Carcinoma of Head and Neck, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Tests That Input Function (IF) Could Be Calculated (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.