Optimized Diffusion-Weighted Imaging for the Evaluation o... | NCT04685798

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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	DWI MRI + Standard of care FDG PET/CT

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Gloria J Guzman Pérez-Carrillo, M.D.	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

Label	URL
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	DWI MRI + Standard of Care FDG PET/CT	-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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 5, 2023

ID	Title	Description
BG000	DWI MRI + Standard of Care FDG PET/CT	-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.

Units	Counts
Participants	BG0008

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00061(42 to 76)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002
Male	BG0006

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000
Not Hispanic or Latino	BG0008

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0008

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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

Evaluable patients include those that received the DWI MRI and the standard of care FDG PET/CT, had measurable disease on imaging, and had tumor persistence/recurrence.

Posted

Mean

Standard Deviation

x 10-6 mm^2/s

2-3 weeks post-standard of care treatment

ID	Title	Description
OG000	DWI MRI + Standard of Care FDG PET/CT	-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.

Units	Counts
Participants	OG0001

Title

Denominators

Categories

Title	Measurements
	OG0001.337± NAThere is only participant evaluable.

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

Evaluable patients include those that received the DWI MRI and the standard of care FDG PET/CT, had measurable disease on imaging, and had tumor persistence/recurrence.

Posted

Number

x 10-6 mm^2/s

2-3 weeks post-standard of care treatment

ID	Title	Description
OG000	DWI MRI + Standard of Care FDG PET/CT	-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.

Units	Counts
Participants

Secondary

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

Evaluable patients include those that received the DWI MRI and the standard of care FDG PET/CT, had measurable disease on imaging, and had tumor persistence/recurrence.

Posted

Count of Participants

Participants

2-3 weeks post-standard of care treatment

ID	Title	Description
OG000	DWI MRI + Standard of Care FDG PET/CT	-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.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DWI MRI + Standard of Care FDG PET/CT	-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.	3	8	0	8	0	8

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D018307	Neoplasms, Squamous Cell

ID	Term
D008279	Magnetic Resonance Imaging
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis