Pancreatic cancer and lung cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 = 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the change in metabolic ratio of the phospholipid metabolites PC, PE, PGE, GPC, Pi, PCr, and energy metabolites ATP from the area under the curve (AUC) of the corresponding spectral peaks between the measurements at baseline (healthy volunteers), before-, during- (patients with pancreatic cancer) and after treatment (chemotherapy or immunotherapy). From patients who underwent surgery (only pancreatic cancer patients), tumor characteristics (pathology results using CAP scoring system32, location of tumor, stage at time of diagnosis) will be assessed to correlate with metabolite ratios in order to make a distinction between tumor biology (based on pathology result; aggressive or non-aggressive tumor) and their response to chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters and endpoints will be 6 and 12 month disease control rate (DCR) according to internationally accepted response evaluation guidelines (RECIST 1.1) and potential surgery outcome (pancreatic cancer patients) based on CT-imaging (division based on the DPCG-criteria30). For the lung cancer cohort, pulmonary toxicity will be scored (secondary objective). Phosphorus MRSI will be used to estimate an effect size for potentially predicting (non)-response and occurrence of severe side-effects of therapy. Multi-variable analysis of clinically relevant data to investigate the feasibility of a dynamic prediction model will use all metabolic imaging data, size measurements from CT, conventional 7T MR imaging scans, coded radiology reports, clinical patient data, details extracted from clinical notes which are coded before storage to preserve anonymity, choice of therapy, progression free survival (PFS) and overall survival (OS). | — |
Countries
Netherlands
Outcome results
None listed