Characterization of Biophysical Stromal Properties in Human Cancer: Towards Personalized Computational Oncology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-11

Study Completion Date

2025-12-31

Brief Summary

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Drug delivery in solid tumors, whether administered systemically or locoregionally, is hindered by an elevated interstitial fluid pressure (IFP). Stromal targeting therapies are in active development, aiming to enhance drug transport after systemic or locoregional delivery. To date, no clinical methods are available to quantify tumor biophysical properties (including IFP). The investigators aim to use a combination of dynamic contrast enhanced MRI and computational fluid modeling (CFD) to measure stromal IFP in patients with pancreatic cancer and in patients with ovarian or colonic peritoneal carcinomatosis (PC). Computational data will be correlated with therapy response, platinum drug penetration, and invasively measured biophysical parameters after intravenous (pancreas) or intraperitoneal (ovarian/colonic PC) administration of a platinum compound. This would be the first in depth clinical study addressing this important topic, and could pave the way to developing personalized computational based treatment approaches aimed at targeting the biophysical environment of the tumor stroma in order to enhance cancer drug delivery.

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Detailed Description

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Conditions

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Carcinomatosis, Peritoneal Pancreas Cancer Ovarian Cancer Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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DCE-MRI

Group Type EXPERIMENTAL

MRI

Intervention Type PROCEDURE

Patients will undergo an MR scan before undergoing cytoreductive surgery. If neoadjuvant chemotherapy is administered, an extra MR scan is planned before the start of the neoadjuvant chemotherapy.

During surgery, tissue samples will be taken for interstitial fluid pressure (IFP) measurement, immunohistochemistry (IHC) and characterization of biophysical properties (viscoelastic properties and hydraulic conductivity).

Interventions

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MRI

Patients will undergo an MR scan before undergoing cytoreductive surgery. If neoadjuvant chemotherapy is administered, an extra MR scan is planned before the start of the neoadjuvant chemotherapy.

During surgery, tissue samples will be taken for interstitial fluid pressure (IFP) measurement, immunohistochemistry (IHC) and characterization of biophysical properties (viscoelastic properties and hydraulic conductivity).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with non-cystic adenocarcinoma the pancreas requiring neoadjuvant chemotherapy (any) because of borderline resectability
* Patients with stage IIIC or IVA ovarian cancer planned for debulking and HIPEC.
* Patients with stage IIIC or IVA colorectal cancer planned for debulking and HIPEC

Exclusion Criteria

* Age \<18 years
* Pregnancy, or suspected inadequate contraception during study period
* Clinically detectable ascites
* Intestinal or urinary tract obstruction
* Hepatic and/or extra-abdominal metastatic disease
* Impaired renal function (serum creatinine \> 1.5mg/dl or calculated GFR (CKD-EPI) \< 60mL/min/1.73 m²)
* Impaired liver function (serum total bilirubin \> 1.5 mg/dl, except for known Gilbert's disease)
* Platelet count \< 100.000/µl
* Hemoglobin \< 9g/dl
* Neutrophil granulocytes \< 1.500/ml
* Irresectable or metastatic disease
* Contra-indication for contrast enhanced MRI

* Known allergy or intolerance to Gadolinium based contrast agents
* Severe claustrophobia
* Patients with metallic foreign bodies (pacemaker, neurostimulator, pedicle screw, cerebral aneurysm clips…) that may dislodge in a strong magnetic field
* Frail and medically unfit patients (Karnofsky index \< 60% and WHO Performance score 3 or 4)
* Estimated life expectancy \< 12 months
* In case of ovarian/colon cancer: no visible peritoneal metastasis on CT scan
* Acute or chronic pancreatitis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No