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

NCT ID: NCT06999538

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-09-01

Brief Summary

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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

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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.

Conditions

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Solid Cancers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Radiologist interpretation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe Aube

Role: STUDY_CHAIR

University Hospital, Angers

Central Contacts

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Christophe Aube

Role: CONTACT

Phone: 241353637

Email: [email protected]

DRCI Promotion interne

Role: CONTACT

Email: [email protected]

Other Identifiers

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49RC25_0203

Identifier Type: -

Identifier Source: org_study_id