A retrospective non-interventional study to evaluate clinical performance of AIQCT software for detection of T-DXd-related ILD in chest CT images.

Optimizing diagnostic test for trastuzumab deruxtecan treatment-related lung disease by using artificial intelligence-based technology for chest computed tomography analysis of interstitial lung disease - TILD-A study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047612

Enrollment

150

Registered

2022-04-28

Start date

2022-04-15

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

Breast Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Breast cancer patients who participated in the phase I study DS8201-A-J101 or phase II study DS8201-A-U201 in Japan and received at least one dose of T-DXd. 2. Patients who have not withdrawn their consent at the time of participating in the phase I study DS8201-A-J101 or phase II study DS8201-A-U201. 3. Patients who have had chest computed tomography examinations (including pre-dose) during T-DXd administration in the Phase I study DS8201-A-J101 or Phase II study DS8201-A-U201, and their CT images and information collected up to the cut-off date of February 1, 2019 in DS8201-A-J101 and March 21, 2019 in DS-8201-A-U201 have been stored at Daiichi Sankyo Co., Ltd. and its contractors.

Exclusion criteria

Exclusion criteria: Patients who expressed non-participation in the study by the person or representative before fixing the data.

Design outcomes

Primary

Measure	Time frame
Diagnosis accuracy rates (sensitivity, specificity, accuracy, positive predictive value, and negative predictive value) of AIQCT for T-DXd-related ILD.	—

Secondary

Measure	Time frame
Physician's diagnostic accuracy rates for T-DXd -related ILD with and without AIQCT assistance.	—

Countries

Japan

Contacts

Public ContactNaoya Tanabe

KYOTO UNIVERSITY Department of Rehabilitation

ntana@kuhp.kyoto-u.ac.jp075-751-3111

Outcome results