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NCT Number: NCT06999538

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiologist interpretation

Other

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

Primary outcomes

  1. Time elapsed between opening and closing, oncology interpretation completed, of the same file interpreted

    Time frame: 1 day

Secondary outcomes

  1. Number of additional relevant lesions discovered

    Time frame: Day 1

  2. Duration recorded for examinations with no relevant lesions and pathological examinations

    Time frame: Day 1

  3. Recorded times for initial and follow-up examinations

    Time frame: Day 1

  4. Location and size of lesion(s) on report and nature of primary tumor in patient file

    Time frame: Day 1

  5. Number of lesions detected

    Time frame: Day 1

    relevant or doubtful lesions by reading with or without Liflow

  6. Number of lesions whose discovery would have led to a change in treatment

    Time frame: day 1

    change in surgical technique, change in chemotherapy, indication of a treatment not initially planned

  7. Number of lesions not retained

    Time frame: day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Aube

CONTACT

[email protected]

241353637 ext. +33

DRCI Promotion interne

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: LiFE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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