Metabolic Imaging to Improve Patient-Specific Therapy Outcome

Recruiting

Conditions: metastatic colon cancer
metastatic gastro-oesophageal cancer
10019654

Registration Number: NL-OMON55904

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

Patients with liver metastasis of gastro-oesophageal cancer, with histological
or cytological proof of
metastasis or a high suspicion on CT imaging whom are scheduled for first line
palliative chemotherapy.

2. 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 claustrophobia; patient with an
abdominal circumference which exceeds MRI-bore circumference.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters include the metabolic ratio of the phospholipids PME<br /><br>and PDE from the area under the curve (AUC) of the corresponding spectral<br /><br>peaks. Metabolites are identified and quantified in the spectra using LCModel<br /><br>and AMARES. Partial least squares discriminant analysis and linear mixed models<br /><br>are used to identify significantly altered phospholipid metabolism. The main<br /><br>endpoint is defined by the RECIST progression criteria after every nine weeks<br /><br>assessed using tumour size measurements from standard-of-care CT scans together<br /><br>with the overall survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters and endpoints include the response to treatment<br /><br>following the RECIST progression criteria, progression free survival, overall<br /><br>survival, ratios of other MR detectable metabolites from multiple nuclei and<br /><br>their individual metabolite changes. </p><br>