The role of the tumor microenvironment of pancreatic cancer to predict treatment outcome

The role of the tumor microenvironment of pancreatic cancer to predict treatment outcome - Microenvironment of pancreatic cancer (MIPA)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44790

Enrollment

Registered

2013-10-28

Start date

2013-11-13

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Patients with pancreatic tumors, with histological or cytological proof of adenocarcinoma or a high suspicion on CT imaging. * Tumor size * 1cm. * WHO-performance score 0-2. * Scheduled for surgery or neo-adjuvant chemotherapy/radiation followed by surgery. For the reproducibility part of the study, patients who will not undergo surgery, may be included, too. * Written informed consent.

Exclusion criteria

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. * Renal failure (GFR

Design outcomes

Primary

Measure	Time frame
For each imaging modalities one parameter will be regarded as primary study endpoint. For DWI the mean ADC of the whole tumor will be taken as primary study endpoint. From the different parameters that can be calculated from DCE-MRI, following the recommendations of the Pharmacodynamic/Pharmacokinetic Technologies Advisory Committee, Drug Development Office, Cancer Research UK, we will use mean Ktrans of whole tumor as primary study endpoint. For T2* the average value of the whole tumor will be taken. For 18F-HX4-PET/CT mean SUV of the whole tumor will be used as primary study end point. For the immunohistochemical analyses marker expression will be assessed in terms of stained surface area relative to the total tumor area.	—

Measure

Time frame

For each imaging modalities one parameter will be regarded as primary study endpoint. For DWI the mean ADC of the whole tumor will be taken as primary study endpoint. From the different parameters that can be calculated from DCE-MRI, following the recommendations of the Pharmacodynamic/Pharmacokinetic Technologies Advisory Committee, Drug Development Office, Cancer Research UK, we will use mean Ktrans of whole tumor as primary study endpoint. For T2* the average value of the whole tumor will be taken. For 18F-HX4-PET/CT mean SUV of the whole tumor will be used as primary study end point. For the immunohistochemical analyses marker expression will be assessed in terms of stained surface area relative to the total tumor area.

—

Secondary

Measure	Time frame
For MRI, as mean values may average out differences and, therefore, underestimate differences in tumor physiology, exploratory histogram analyses will be performed. For 18F-HX4-PET/CT SUVmax will be determined as an exploratory endpoint.	—

Countries

Netherlands

Outcome results