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

Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04685798
• Other study ID #: 201912072
• Status: Terminated
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: September 26, 2023

Study information

• Verified date: October 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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

External Links

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