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

NCT04685798 | Terminated Results DMC FDA Device

• 1 other identifier: 201912072
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of Participants That Were Non-responders to Treatment on Both the DWI MRI and the Standard of Care FDG PET/CT

  2-3 weeks post-standard of care treatment

Study Arms (1)

DWI MRI + Standard of care FDG PET/CT

EXPERIMENTAL

-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; Device: FDG PET/CT

Interventions

Diffusion-weighted imaging magnetic resonance imaging DEVICE

The research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system

Also known as: DWI MRI

DWI MRI + Standard of care FDG PET/CT

FDG PET/CT DEVICE

Standard of care

DWI MRI + Standard of care FDG PET/CT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Diffusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Gloria J. Guzman Pérez-Carrillo, M.D.
• Organization: Washington University School of Medicine

guzman.gloria@wustl.edu

314-362-5950

Study Officials

• Gloria J Guzman Pérez-Carrillo, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All anonymized MRI studies will be blindly evaluated by at least two experienced neuroradiologists
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 28, 2020
• Study Start: September 2, 2020
• Primary Completion: September 26, 2023
• Study Completion: September 26, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)