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fficacy evaluation test of FS-AI688

Efficacy evaluation study comparing physician alon e and FS-AI688 combination for diagnostic ability f or pulmonary nodules.

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1030240309
Enrollment
390
Registered
2024-08-31
Start date
2024-08-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

None listed

Sponsors

Machida Tadashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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).

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
FOM (Figure of merit)

Secondary

MeasureTime frame
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

Contacts

Public ContactTadashi Machida

Nippon Medical School Hospital

zeke@nms.ac.jp+81-3-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026