Measuring tumor properties to improve cancer treatment
Characterization of Biophysical Stromal Properties in Human Cancer: Towards Personalized Computational Oncology
NA · University Hospital, Ghent · NCT04512209
This study is testing if measuring certain properties of tumors can help improve drug delivery and treatment for patients with pancreatic cancer and those with ovarian or colorectal cancer receiving chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Gent and 1 other locations) |
| Trial ID | NCT04512209 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance drug delivery in solid tumors by measuring the biophysical properties of tumor stroma, particularly interstitial fluid pressure (IFP), using dynamic contrast enhanced MRI and computational fluid modeling. It focuses on patients with pancreatic cancer and those with ovarian or colorectal peritoneal carcinomatosis who are undergoing chemotherapy. By correlating the measured stromal properties with therapy response and drug penetration, the study seeks to develop personalized treatment strategies for these patients. This is the first clinical effort to quantify these important tumor characteristics.
Who should consider this trial
Good fit: Ideal candidates include patients with borderline resectable pancreatic adenocarcinoma or stage IIIC/IVA ovarian or colorectal cancer planned for surgery and chemotherapy.
Not a fit: Patients with metastatic disease, significant organ dysfunction, or contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved drug delivery and treatment outcomes for patients with specific types of cancer.
How similar studies have performed: While this approach is novel in clinical settings, similar methodologies have shown promise in preclinical studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gent and 1 other locations
- Ghent University Hospital — Gent, Belgium (RECRUITING)
- Ghent University Hospital — Ghent, Belgium (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Carcinomatosis, Peritoneal, Pancreas Cancer, Ovarian Cancer, Colon Cancer