Status:
RECRUITING
Characterization of Biophysical Stromal Properties in Human Cancer: Towards Personalized Computational Oncology
Lead Sponsor:
University Hospital, Ghent
Conditions:
Carcinomatosis, Peritoneal
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04512209
Start Date
October 11 2019
End Date
December 31 2025
Last Update
February 28 2024
Active Locations (2)
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1
Ghent University Hospital
Ghent, Belgium, 9000
2
Ghent University Hospital
Ghent, Belgium, 9000