TOwards Personalized multi-modality esophageal cancer treatment using machine learning-based Quantitative MRI

Recruiting

Conditions: 10017991
10017990
esophageal cancer
tumour pathophysiology

Registration Number: NL-OMON56160

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 65

Inclusion Criteria

1. Patients with biopsy-proven esophageal cancer (adenocarcinoma)
2. WHO-performance score 0-2.
3. Written informed consent.

For sub-study III, subjects must also meet the following criterium:
4. Planned for neoadjuvant chemoradiotherapy and surgery with curative intent
(cT1-4a, N0-3, M0)

Exclusion Criteria

1. Contra-indications for MR scanning.
2. Contra-indications for Gadolinium-based contrast injection, including known
renal insufficiency (eGFR<30 ml/min/1.73m2) and known allergic reaction to
gadolinium-based contrast agent.
3. Age < 18 years

For sub-study III, potential subjects who meet the following criteria will be
excluded from participation in this study:
4. Previous treatment for esophageal cancer

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sub-study I:No quantitative endpoints will be derived. Success will be defined<br /><br>as having a high-quality fast quantitative MRI protocol for multi-contrast<br /><br>imaging of tumour pathophysiology at 3T. This includes: visibility of tumor<br /><br>tissue on the individual MR images, visibility of tumor tissue on the derived<br /><br>quantitative MRI parameter maps and adequate signal to noise ratio in the tumor<br /><br>tissue<br /><br>Sub-study II: Inter- and intra-session repeatability coefficient are assessed,<br /><br>based on the standard deviation of repeated measures, indicating 95% CI of<br /><br>repeated measures.<br /><br>Sub-study III: The effect size of quantitative MRI parameters: f at MRI-1,<br /><br>Ktrans at MRI-1, ΔD from MRI-1 to MRI-3 for prediction of the presence of<br /><br>residual tumor in the ex vivo surgical specimen in individual esophageal cancer<br /><br>patients</p><br>

Secondary Outcome Measures