Real-life Performance Evaluation of the LiFlow X-ray Platform
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiologist interpretation.
- Who it may be relevant to
- Registry conditions: Solid Cancers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Radiologist interpretation
two interpretations (with and without Liflow, oncology imaging tool).
Primary outcome measures
- Time elapsed between opening and closing, oncology interpretation completed, of the same file interpreted [Time frame: 1 day]
Secondary outcome measures (7)
- Number of additional relevant lesions discovered [Time frame: Day 1]
- Duration recorded for examinations with no relevant lesions and pathological examinations [Time frame: Day 1]
- Recorded times for initial and follow-up examinations [Time frame: Day 1]
- Location and size of lesion(s) on report and nature of primary tumor in patient file [Time frame: Day 1]
- Number of lesions detected [Time frame: Day 1]
- Number of lesions whose discovery would have led to a change in treatment [Time frame: day 1]
- Number of lesions not retained [Time frame: day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06999538 · 49RC25_0203