Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT

The investigators propose a longitudinal study evaluating post-treatment changes in patients with squamous cell carcinoma (SCC) of the neck using an innovative optimized diffusion-weighted imaging (DWI) pulse sequence to identify more accurately recurrent tumors as well as early non-responders to therapy.

Study Overview

• Status: Terminated
• Conditions: Squamous Cell Carcinoma
• Intervention / Treatment: Device: Diffusion-weighted imaging magnetic resonance imaging

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically-proven newly diagnosis or recurrence as indicated by tissue diagnosis of T3 or T4 squamous cell carcinoma of the head and neck
• Must have had or be scheduled for standard-of-care surgical resection, radiation, and/or chemo-radiation of the diagnosed squamous cell carcinoma of the head and neck
• At least 18 years of age
• Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

• Contraindications to MRI, including:

  • MRI-incompatible implantable devices
  • severe claustrophobia; and
• Pregnant and/or breastfeeding, with women of childbearing potential having a negative urine or serum pregnancy test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWI MRI; -The patients will undergo an optimized research neck DWI MRI, up to 3 weeks post-treatment and then a standard-of-care 3-month post-treatment FDG PET/CT examination.	Device: Diffusion-weighted imaging magnetic resonance imaging; The research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system; Other Names: DWI MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apparent diffusion coefficient mean (ADCmean)	ADC=measure of the magnitude of diffusion (of water molecules) within tissue; The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images & then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis; A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI); ADCmean will describe distribution of ADC measurements in tumor/non-tumor tissues & independent sample t-test will compare ADC measurements between the 2 groups	2-3 weeks post-standard of care treatment
Apparent diffusion coefficient lowest value in a tumor (ADCmin)	ADC=measure of the magnitude of diffusion (of water molecules) within tissue; The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images & then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis; A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI); ADCmin will describe distribution of ADC measurements in tumor/non-tumor tissues & independent sample t-test will compare ADC measurements between the 2 groups	2-3 weeks post-standard of care treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of non-responders to treatment as measured by DWI MRI as compared to the number of non-responders to treatment as measured by FDG PET/CT	2-3 weeks post-standard of care treatment

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Gloria J Guzman Pérez-Carrillo, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: 201912072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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