Trial Outcomes & Findings for Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT (NCT NCT04685798)

Last Updated: 2024-09-19

Results Overview

* 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

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

2-3 weeks post-standard of care treatment

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Did not have standard of care FDG PET/CT	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DWI MRI + Standard of Care FDG PET/CT n=8 Participants -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.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-3 weeks post-standard of care treatment

Population: 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.

Outcome measures

Outcome measures
Measure	DWI MRI + Standard of Care FDG PET/CT n=1 Participants -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.
Apparent Diffusion Coefficient Mean (ADCmean)	1.337 x 10-6 mm^2/s Standard Deviation NA There is only participant evaluable.

PRIMARY outcome

Timeframe: 2-3 weeks post-standard of care treatment

Population: 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.

* 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

Outcome measures

Outcome measures
Measure	DWI MRI + Standard of Care FDG PET/CT n=1 Participants -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.
Apparent Diffusion Coefficient Lowest Value in a Tumor (ADCmin)	1.007 x 10-6 mm^2/s

SECONDARY outcome

Timeframe: 2-3 weeks post-standard of care treatment

Population: 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.

Outcome measures

Outcome measures
Measure	DWI MRI + Standard of Care FDG PET/CT n=1 Participants -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.
Number of Participants That Were Non-responders to Treatment on Both the DWI MRI and the Standard of Care FDG PET/CT	1 Participants

Adverse Events

DWI MRI + Standard of Care FDG PET/CT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gloria J. Guzman Pérez-Carrillo, M.D.

Washington University School of Medicine

Phone: 314-362-5950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place