Peritoneal Carcinomatosis Clinical Trial
Official title:
Diagnostic Value of Diffusion-weighted Magnetic Resonance Imaging for Detection of Peritoneal Metastases in High-risk Pancreatic Ductal Adenocarcinoma: a Pilot Study.
Diffusion-weighted magnetic resonance imaging (DWI/MRI) has been described in recent literature as a highly sensitive and specific modality for the detection of peritoneal metastases (PM). It has been demonstrated to be superior to computed tomography (CT) for patients with known peritoneal disease from colorectal and gynaecological malignancies. However, the literature is scarce on the role of DWI/MRI in patients with pancreatic ductal-adenocarcinoma (PDAC). The aim of this study is to prospectively assess the added value of whole-body DWI/MRI (WB-DWI/MRI) to CT for detection of PM in the preoperative staging of patients with high-risk PDAC and evaluate how it correlates with intraoperative findings.
This is a prospective study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough assessment for resectability, patients with PDAC considered resectable based on CT, but at high-risk for peritoneal disease, will be prospectively included in the study and assessed with WB-DWI/MRI within 4 weeks of the planned surgery, with the standard protocol including the following sequences: Patients will drink 1L of pineapple juice one hour prior to the examination in order to provide a negative intraluminal contrast. Patients will receive 20 mg of intravenous hyoscine butylbromide at the beginning of the MR exam in order to reduce bowel peristalsis. Sequences will include Axial et Coronal T2WI of the abdomen and pelvis, axial DWI with b values of 0, 50 and 1000 of the abdomen and pelvis, as well as Pre and post gadolinium-based contrast Axial and Coronal 3D T1WGRE. Patients with no evidence of PM on WB-DWI/MRI will be operated on and undergo pancreatic resection following the usual exploration of the peritoneal cavity in case of occult metastatic disease. Patients with suspicion of PM on WB-DWI/MRI will be approached with a diagnostic laparoscopy first, then undergo pancreatic resection if no evidence of PM is found. Each case will be followed for at least 6 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04826432 -
Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis
|
Phase 2 | |
| Recruiting |
NCT03127774 -
Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma
|
Phase 2 | |
| Recruiting |
NCT04024917 -
Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis
|
N/A | |
| Active, not recruiting |
NCT03508570 -
Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis
|
Phase 1 | |
| Not yet recruiting |
NCT04352894 -
Intraoperative ICG Fluorescence Imaging for Peritoneal Carcinomatosis Detection
|
N/A | |
| Completed |
NCT06318793 -
Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis
|
||
| Completed |
NCT05547568 -
A Nomogram to Predict Major Postoperative Complications After Cytoreductive Surgery and HIPEC Based on Pre and Peroperative Criteria: Which Patient Require Intensive Monitoring?
|
||
| Terminated |
NCT01683864 -
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04547725 -
Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis
|
N/A | |
| Completed |
NCT03304210 -
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
|
Phase 1 | |
| Withdrawn |
NCT03682744 -
CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
|
Phase 1 | |
| Terminated |
NCT04047771 -
A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis
|
Phase 1 | |
| Recruiting |
NCT05623787 -
Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms
|
N/A | |
| Recruiting |
NCT05063019 -
Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index
|
N/A | |
| Completed |
NCT02891447 -
Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer
|
Phase 2 | |
| Recruiting |
NCT04231175 -
Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer
|
N/A | |
| Not yet recruiting |
NCT04734691 -
Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study
|
Phase 2 | |
| Recruiting |
NCT04108936 -
Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses
|
||
| Completed |
NCT02604784 -
Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01764789 -
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
|
N/A |