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

NCT04266470 | Withdrawn FDA Device

• 3 other identifiers: IRB00056907P30CA012197WFBCCC 01919
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Monitoring blood flow; Metabolic activity in malignant tissue - head/ neck; Tumor response to therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline

Secondary Outcomes (2)

• Change in Areas Under the Curve (AUC) Measurements

  Baseline up to 120 days after completion of treatment

• Change in Time to Peak Arterial Blood Flow

  Baseline up to 120 days after completion of treatment

Other Outcomes (1)

• Tumor Response

  Baseline and 120 days after completion of treatment

Study Arms (1)

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

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

Interventions

Lara Scan DEVICE

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.

Lara Device Scan

PET/CT Scan - Pre-treatment and Post-treatment DIAGNOSTIC_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.

Lara Device Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Bart Frizzell, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: March 9, 2020
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share