on-Ionizing Metabolic Imaging using robust phosphorus MRI to predict treatment efficacy.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

Inclusion criteria for pancreatic cancer:
To be eligible to participate in this study, a subject must meet all of the
following criteria:
• Patients with (borderline) resectable- or locally advanced pancreatic cancer,
with histological or cytological proof, scheduled for standard of care
chemotherapy containing fluorouracil, oxaliplatin, irinotecan and leucovorin
(FOLFIRINOX) as assessed by a medical oncologist.
• Tumour size >= 1cm.
• WHO-performance score 0-1, weight >=40kg
• Written informed consent.

Inclusion criteria healthy volunteers (control group pancreas cohort):
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Healthy volunteers; No history of cancer, no history of chronic diseases, no
history of a pancreatic disease, no elective surgery <8 weeks
• Age: >= 18yrs
• WHO-performance score 0-2.
• Written informed consent.

Inclusion criteria for lung cancer:
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Patients with non-small cell lung cancer, with histological or cytological
proof, scheduled for immune checkpoint inhibitors
• Tumour size >= 2cm.
• WHO-performance score 0-2, weight >=40kg
• Written informed consent.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Any psychological, familial, sociological, or geographical condition
potentially hampering adequate informed consent or compliance with the study
protocol.
• Contra-indications for 7T 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 and/or obesitas.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change in metabolic ratio of the phospholipid<br /><br>metabolites PC, PE, PGE, GPC, Pi, PCr, and energy metabolites ATP from the area<br /><br>under the curve (AUC) of the corresponding spectral peaks between the<br /><br>measurements at baseline (healthy volunteers), before-, during- (patients with<br /><br>pancreatic cancer) and after treatment (chemotherapy or immunotherapy). From<br /><br>patients who underwent surgery (only pancreatic cancer patients), tumor<br /><br>characteristics (pathology results using CAP scoring system32, location of<br /><br>tumor, stage at time of diagnosis) will be assessed to correlate with<br /><br>metabolite ratios in order to make a distinction between tumor biology (based<br /><br>on pathology result; aggressive or non-aggressive tumor) and their response to<br /><br>chemotherapy. </p><br>

Secondary Outcome Measures