Real-life Performance Evaluation of the LiFlow X-ray Platform (LiFE)

The thoraco-abdomino-pelvic (TAP) scanner is crucial for assessing and monitoring solid cancers. However, advancements in scanner technology have led to a significant increase in data volume, from 100 images per exam 20 years ago to 2,000 today. The rising number of cancer cases and treatments requiring closer monitoring further strain the workload, prolonging interpretation time and causing delays in therapeutic management and adjustments. The limited number of radiologists contributes to this saturation, increasing the risk of missing metastatic lesions, especially in the lungs, liver, bones, peritoneum, and lymph nodes. The RECIST 1.1 criteria, introduced 15 years ago for standardized follow-up, are useful but time-consuming to implement, resulting in only a small fraction of oncology CT reports using them.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Cancers
• Intervention / Treatment: Other: Radiologist interpretation

Detailed Description

The LiFE study consists in retrospectively interpreting the TAP scans of patients who have agreed to take part in the study at two separate times, once without the LiFlow tool and once with it, at least 8 weeks after the scan date. To avoid any memory effect, a washout period of 8 weeks will be observed between these two interpretations. The study will involve 10 radiologists and 400 patients. Each scan will be interpreted twice by the same doctor (with and without the LF tool). During the second retrospective interpretation, the radiologist will assess the impact of of the additional lesions discovered by LiFlow on the patient's therapeutic management. The notion of change in management is defined by a change in treatment, such as a change in surgical technique, a change in chemotherapy or an indication for a treatment not initially planned. In addition, for these lesions, a gold standard will be obtained (an opinion from one or two other radiologists and/or other characterization imaging and/or biopsy/histology and/or follow-up of the lesion).

The aim of the study is to validate the time saved on interpretations and reports, and to improve the accuracy of TAP scan interpretation.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: DRCI Promotion interne; Email: drci-promotion-interne@chu-angers.fr
• Study Contact Backup: Name: Christophe Aube; Phone Number: +33 241353637; Email: christophe.aube@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients treated for solid cancer

Description

Inclusion Criteria:

• TAP (thoraco-abdomino-pelvic) scans
• Age > 18 years

Exclusion Criteria:

• Examination of imperfect quality due to movement or breathing,
• Inability to inject contrast medium or incomplete injection
• refusal to use data

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time elapsed between opening and closing, oncology interpretation completed, of the same file interpreted	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of additional relevant lesions discovered		Day 1
Duration recorded for examinations with no relevant lesions and pathological examinations		Day 1
Recorded times for initial and follow-up examinations		Day 1
Location and size of lesion(s) on report and nature of primary tumor in patient file		Day 1
Number of lesions detected	relevant or doubtful lesions by reading with or without Liflow	Day 1
Number of lesions whose discovery would have led to a change in treatment	change in surgical technique, change in chemotherapy, indication of a treatment not initially planned	day 1
Number of lesions not retained		day 1

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Study Chair: Christophe Aube, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 22, 2025
• First Submitted That Met QC Criteria: May 22, 2025
• First Posted (Actual): May 31, 2025

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 49RC25_0203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No