Improving preoperative staging in patients with locally resectable pancreatic cancer – a randomised controlled trial comparing 12 month recurrence rate of patients managed with standard preoperative assessment of liver metastases, contrast enhanced CT( computed tomography) to preoperative assessment of liver metastases with Primovist (liver specific contrast) MRI ( magnetic resonance imaging )

Phase 2

• Conditions: pancreas adenocarcinoma; Cancer - Pancreatic

• Registration Number: ACTRN12614001287628
• Lead Sponsor: jai seema bagia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Sex: Male and Females

Age range: 18-85

Disease status: Locally operable pancreatic adenocarcinoma diagnosed by CT +- elevated tumour markers +- cholangiography +- cytology.

No liver metastases on CT staging.

Exclusion Criteria

Patients with significant renal impairment, which precludes them having the CT, contrast or Primovist contrast for the MRI would be excluded.

Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.

Patients with a history of renal disease with an EGFR less than 40.

Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.

Patients with devices that exclude them from Primovist MRI will be excluded from the study, in particular, patients with pacemakers and/or implantable devices.

Patients unwilling and unable to give written informed consent to participate in the study. Patients unable to understand study information with the help of an interpreter.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrence rate<br><br>evaluated with multiphase CT chest abdomen and pelvis and tumor marker Ca 19-9 every 3 months ( as is usual followup in this group)[12 months]

Secondary Outcome Measures

Name	Time	Method
liver metastases as seen on CT, MRI or PET<br><br>however only CT is part of routine followup <br>if other modalities are used as part of clinical workup to further evaluate a finding the information from this imaging will be noted[12 months]