Pretreatment contrast-enhanced MRI with diffusion-weighted imaging to find hidden liver metastases in pancreatic cancer
PRetreatment MRI for OCcult Liver Metastasis Assessment In Pancreatic Ductal adenocarcinoMa. An International Multicentric, Prospective, Diagnostic Accuracy Trial
This project will test whether adding contrast-enhanced MRI with diffusion-weighted imaging before treatment can find hidden liver metastases in adults newly diagnosed with pancreatic ductal adenocarcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria Academic / other |
| Locations | 1 site (Alessandria, Piedmont) |
| Trial ID | NCT07252076 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls adults with a new cytological or histological diagnosis of pancreatic ductal adenocarcinoma and no signs of metastasis on initial CT. Participants undergo contrast-enhanced MRI including diffusion-weighted imaging within three weeks of the diagnostic CT to search for occult liver metastases. Findings from MRI will be compared with initial CT results and any intraoperative or follow-up findings to determine how often MRI detects lesions missed by CT. The goal is to refine pre-treatment staging and reduce unnecessary surgery by improving detection of small liver metastases.
Who should consider this trial
Good fit: Adults (over 18) with a new cytological or histological diagnosis of pancreatic ductal adenocarcinoma, a CT showing localized pancreatic disease, no prior treatment, and ability to provide informed consent are ideal candidates.
Not a fit: Patients who already have metastatic disease visible on initial CT or who have received prior treatment for their pancreatic disease are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could detect small liver metastases earlier and help avoid unnecessary surgery for patients with pancreatic cancer.
How similar studies have performed: Previous smaller studies and case series have suggested that contrast-enhanced MRI with diffusion-weighted imaging can reveal occult liver metastases missed by CT, but evidence remains limited and not yet routine.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients over 18 years of age. * Patients with a new cytological or histological diagnosis of PDAC. * A CT scan demonstrating pancreatic disease and meeting the minimum criteria for the imaging assessment of pancreatic gland tumors (see section 4.6, study procedures). * An MRI performed no later than 3 weeks after the CT scan, also meeting the minimum radiological criteria (see section 4.6, study procedures). * No prior treatment for pancreatic disease. * Patients able to receive and understand the study information and to provide written informed consent duly signed by both the patient and the investigator. Exclusion Criteria: * Signs of metastatic disease on the initial CT scan (hepatic, pulmonary, distant lymph node, peritoneal carcinomatosis, or other organ involvement).
Where this trial is running
Alessandria, Piedmont
- SC Chirurgia Generale — Alessandria, Piedmont, Italy (Recruiting)
Study contacts
- Study coordinator: Clinical Trial Center Clinical Trial Center
- Email: clinicaltrialcenter@ospedale.al.it
- Phone: 0131206893
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.