esophageal cancer tumour pathophysiology
Conditions
Interventions
None listed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 therapy and surgery with curative intent (cT1-4a, N0-3, M0)
Exclusion criteria
Exclusion criteria: 1. Contra-indications for MR scanning. 2. Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sub-study I:No quantitative endpoints will be derived. Success will be defined as having a high-quality fast quantitative MRI protocol for multi-contrast imaging of tumour pathophysiology at 3T. This includes: visibility of tumor tissue on the individual MR images, visibility of tumor tissue on the derived quantitative MRI parameter maps and adequate signal to noise ratio in the tumor tissue Sub-study II: Inter- & intra-session repeatability coefficient are assessed, based on the standard deviation of repeated measures, indicating 95% CI of repeated measures. Sub-study III: The effect size of quantitative MRI parameters: f at MRI-1, Ktrans at MRI-1, ΔD from MRI-1 to MRI-3 for prediction of the presence of residual tumor in the ex vivo surgical specimen in individual esophageal cancer patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Sub-study II: - Inter- & intra-session coefficient of variation for the repeatability are assessed, indicating variation of the measurement compared to the mean in percentages. - Baseline characteristics (mean and standard deviation) on the quantitative MRI parameter maps (D, D*, f, T2*, T2 and T1) of the esophageal tumor. Sub-study III: - Area under the curve (AUC) of receiver-operator characteristic (ROC) analysis of quantitative MRI parameters at MRI-1, MRI-2, MRI-3 for prediction of the presence of residual tumor in the ex vivo surgical specimen in individual esophageal cancer patients. - Spatial correlation of quantitative MRI parameters to histopathology of ex vivo surgical specimens - Response of quantitative MRI parameters (D, D*, f, Ktrans, Kep, Ve, Vp, T2*, T2 and T1) to neoadjuvant therapy on individual esophageal cancer patients - Correlation between the baseline quantitative MRI parameters (D, D*, f, Ktrans, Kep, Ve, Vp, T2*, T2 and T1) and treatment efficacy (MRI1) - Correlation between the change in quantitative MRI parameters (D, D*, f, Ktrans, Kep, Ve, Vp, T2*, T2 and T1) and treatment efficacy (MRI1, MRI2 & MRI3) - Correlation between the quantitative MRI parameters (D, D*, f, Ktrans, Kep, Ve, Vp, T2*, T2 and T1) and 18-F-FDG-PET-CT parameters | — |
Countries
Netherlands
Outcome results
None listed