Innovative MRI techniques to improve treatment stratification of patients with Esophageal cancer: an optimization and pilot study

Completed

Conditions: Esophageal cancer
esophageal tumor
10017991

Registration Number: NL-OMON44292

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Volunteers:
• Written informed consent.;Patients:
• Patients with biopsy proven esophageal cancer (squamous cell carcinoma or adenocarcinoma).
• Suspected nodal involvement on EUS or CT at diagnosis.
• WHO-performance score 0-2.
• Scheduled for surgery.
• Written informed consent.

Exclusion Criteria

• Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
• Contra-indications for MR scanning, including patients with a pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; or a non-MR compatible aneurysm clip in their brain; patients with severe claustrophobia.
• Active inflammatory diseases
• History of anaphylaxis or other hypersensitivity reactions
• History of iron overload
• History of abnormal liver function, or elevated liver enzymes (ALAT, ASAT > 3 times upper limit of normal)
• Elevated Serum Transferrin Saturation (TSAT) (>50%) or hemoglobin (>10.5mmol/L)
• Deminished kidney function (eGFR<60)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For USPIO MRI the main endpoint is the change in T2 and T2* at the tumor and<br /><br>lymph nodes on MRI after the administration of USPIO.<br /><br>For DWI the main endpoint is the perfusion fraction f and the diffusion<br /><br>coefficient D obtained by IVIM of the primary tumor.<br /><br>For T2* MRI the main endpoint is T2* of the primary tumor.<br /><br>For DCE MRI the main endpoint is the 'transfer constant' Ktrans and 'rate<br /><br>constant' kep, of the (remaining) primairy tumor</p><br>

Secondary Outcome Measures