About this trial
The TAILLE study is a single-center, non-interventional (RIPH3), uncontrolled, non-randomized, open-label study.prospective study conducted at CHU Grenoble Alpes.
The goal is to evaluate the reliability of an AI algorithm developed as part of the TAILLE-pilot study to estimate height from abdominal CT scan data and relevant clinical data like age and gender.
The TAILLE-pilot study , is a pilot data study (RNIPH) aimed at developing artificial intelligence algorithms using a retrospective cohort, developed by our team. It is based on AI algorithms trained to predict height from abdominal CT scan volumes.
The TAILLE study therefore aims to prospectively evaluate the performance of this algorithm in a new cohort of adult patients scheduled for an abdominal CT scan. We hypothesize that height can be reliably estimated using this algorithm, potentially with greater accuracy at the individual level than self-reported height, the limitations of which have been documented in the literature.
As part of the TAILLE study, we will compare three methods of height estimation or measurement :
* CRA-measured height: height measured by a Clinical Research Associate (CRA), serving as the reference method; * AI-estimated height: height estimated by the AI algorithm developed as part of the TAILLE-pilot study; * Self-reported height: height reported by the patient.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with a scheduled appointment for an abdominal CT scan in the Radiology Department of CHUGA
Patient able to stand for height measurement
Patient who does not object to participating in the study
Patient affiliated with a social security
Disqualifiers
Patient with amputation of at least one limb
Patient with metallic hardware in the spine (artifact)
Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Trial population
Patient with a scheduled appointment for an abdominal CT scan in the Radiology Department of CHUGA
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Assessment of the reliability of an AI algorithm developed as part of the TAILLE-pilot study to estimate height from abdominal CT scan and relevant clinical data, such as gender and sex
Assessment of the differences between CRA-measured height and AI-estimated height (CRA = Clinical Research Associate). CRA-measured height is the reference
Secondary outcomes
Assessment the most reliable method for height estimation by comparing self-reported and AI-estimated height with CRA-measured height
Differences between CRA-measured height and self-reported height, and between CRA-measured height and AI-estimated height
Identification of factors that may influence the reliability of the AI algorithm for height estimation, particularly gender and age
Difference between CRA-measured height and AI-estimated height according to factors that may affect the reliability of the algorithm, particularly gender and age
Assessment of the impact of using self-reported height and AI-estimated height on sarcopenia risk classification
In a hypothetical clinical context, change in sarcopenia risk category according to the SMI value calculated from the muscle area determined by the ODIASP software. Sarcopenia risk will be defined according to the thresholds established by the French National Authority for Health (HAS): men, SMI \< 52.4 cm²/m²; women, SMI \< 38.5 cm²/m²
Assessment of the impact of using self-reported height and AI-estimated height on the calculation of the theoretical chemotherapy dose
In a hypothetical clinical context, percentage of patients receiving a chemotherapy dose lower than 85% of the theoretical dose, a threshold below which impaired prognosis has been reported (Nielson et al., 2021). The dose will be calculated based on body surface area, which depends on the weight measured by the CRA and height. The analyses will focus in particular on commonly used chemotherapy regimens for gastrointestinal cancers: 5-fluorouracil 2,400 mg/m², gemcitabine 1,000 mg/m², and oxaliplatin 85 mg/m²
Sponsors and contacts
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