fficacy evaluation test of FS-AI688

JRCT ID: jRCT1030240309

Registered date:31/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Lung Cancer
• Date of first enrollment: 31/08/2024
• Target sample size: 390
• Study type: Observational

Outcome(s)

• Primary Outcome: FOM (Figure of merit)

Secondary Outcome

Reading test
1.The detectability (sensitivity, average number of false positives, and positive predictive value)of the nodule unit is calculated.
2.Subgroup analysis of the detectability (sensitivity, mean number of false positives, and positive predictive value)of the nodule unit according to the following factors.
Additionally, FOM will be calculated for the interpreter group.
Nodule type
Nodule location
Relationship to the surrounding structure of the nodule
Maximum diameter of the nodule
Slice thickness
Contrast/non-contrast
Imaging research institute
Imaging equipment
Group of interpreters (specialists/late residents).
3.The detectability (sensitivity, specificity, positive predictive value, and negative predictive value) of each case is calculated.
4.Subgroup analysis of the detectability (sensitivity, specificity, positive predictive value, and negative predictive value) of the case unit is performed according to the following factors:
Slice thickness
Contrast/non-contrast
Imaging research institute
Imaging equipment
Reading physicians
5.To evaluate the effect of false positives in the nodal units

Single performance test
1.The detectability (sensitivity, average number of false positives, and positive predictive value) of the nodule unit is calculated.
2.Subgroup analysis of the detectability (sensitivity, mean number of false positives, and positive predi
ctive value)of the nodule unit according to the following factors.
Nodule type
Nodule location
Relationship to the surrounding structure of the nodule
Maximum diameter of the nodule
Slice thickness
Contrast/non-contrast
Imaging research institute
Imaging equipment
Lung field condition/mediastinum condition
3.The detectability (sensitivity, specificity, positive predictive value, and negative predictive value) of e
ach case is calculated.
4.Subgroup analysis of the detectability (sensitivity,
specificity, positive predictive value, and negative p redictive value) of the case unit is performed accor
ding to the following factors:
Slice thickness
Contrast/non-contrast
Imaging research institute
Imaging equipment
Lung field condition/mediastinum condition

common to each study
1.To evaluate the concordance rate of GS.
For GS agreement, the following is calculated:
Case adoption rate, mean number of false positives, and false negative rate of every GS author for GS
Percentage of GS by Combination of GS Creators
Positive agreement of GS author
Summarized statistic of Bounding Box by combination of GS and individual GS producers
Summarized statistic of differences in Bounding Box and relative differences by combination between
GS and individual GS producers
Summarized statistic of Dice factors for Bounding
Box between GS and individual GS producers

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients who had a chest CT scan conducted bet
ween January 1, 2020 and March 31, 2024 at Nipp
on Medical School Hospital or Amakusa Regional
Medical Center, Amakusa County Medical Associat
ion.
2.Patients who have undergone chest CT imaging
who meet the following imaging conditions
CT image size:512 x 512
Slice thickness:5 mm or less
Slice interval:5 mm or less (gapless)
Imaging conditions:Image quality is suitable for inte
rpretation. This is a chest image that allows you to
see the entire lung field.
Reconstruction conditions: There are images for bo
th lung field and mediastinal conditions (the contra
st conditions match, and the slice thickness and int
erval are the same).

Exclude criteria

1. Minor patients (under 18 years old)
2.Patients who have indicated their intention to refu
se to participate in the study by the research subje
ct or their legal representative
3.Other patients who are judged to be inappropriat
e for participation in this study by the principal inve
stigator or co-investigator.

Related Information

• Primary Sponsor: Machida Tadashi