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Real-life Performance Evaluation of the LiFlow X-ray Platform

Real-life Performance Evaluation of the LiFlow X-ray Platform

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06999538
Acronym
LiFE
Enrollment
400
Registered
2025-05-31
Start date
2025-09-01
Completion date
2026-09-01
Last updated
2025-05-31

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

Conditions

Solid Cancers

Brief summary

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.

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.

Interventions

two interpretations (with and without Liflow, oncology imaging tool).

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time elapsed between opening and closing, oncology interpretation completed, of the same file interpreted1 day

Secondary

MeasureTime frameDescription
Number of lesions whose discovery would have led to a change in treatmentday 1change in surgical technique, change in chemotherapy, indication of a treatment not initially planned
Number of lesions not retainedday 1
Duration recorded for examinations with no relevant lesions and pathological examinationsDay 1
Number of additional relevant lesions discoveredDay 1
Location and size of lesion(s) on report and nature of primary tumor in patient fileDay 1
Number of lesions detectedDay 1relevant or doubtful lesions by reading with or without Liflow
Recorded times for initial and follow-up examinationsDay 1

Contacts

Primary ContactChristophe Aube
christophe.aube@chu-angers.fr241353637
Backup ContactDRCI Promotion interne
drci-promotion-interne@chu-angers.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026