The Prediction Using Diffusion MRI of the Response Evaluation in BRPC in NAT.
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      To investigate the correlation between pretreatment ADC value of diffusion MRI and pathologic
      response in patients with borderline resectable pancreatic carcinoma who undergo neoadjuvant
      therapy.
    

Detailed description: 
      Aim: The prediction using diffusion-weighted MRI of the response evaluation in borderline
      resectable pancreatic cancer.

      Study design: Single institution. Single arm. Prospective Phase II Study.

      Number of case: 28

      Patients: The prediction using dMRI of the response evaluation in borderline resectable
      pancreatic carcinoma (BRPC) in neoadjuvant therapy.

      Disease: Pancreatic carcinoma

      Method: To investigate the correlation between pretreatment ADC value of diffusion MRI and
      pathologic response in patients with borderline resectable pancreatic carcinoma who undergo
      neoadjuvant therapy.

      The correlation between pretreatment ADC value of diffusion MRI and pathologic response
      evaluated by Evans grade in patients with borderline resectable pancreatic carcinoma (BRPC)
      who undergo neoadjuvant therapy.

        1. The correlation between pretreatment ADC value at the abutment site of BRPC and the rate
           of tumor cell destruction.

        2. The correlation between posttreatment ADC value at the abutment site of BRPC and the
           rate of tumor cell destruction.

        3. The correlation between the ratio of posttreatment/pretreatment ADC value at the
           abutment site of BRPC and the rate of tumor cell destruction.

        4. The correlation between pretreatment ADC value of BRPC tumor in a largest diameter and
           the rate of tumor cell destruction.

        5. The correlation between the ratio of posttreatment/pretreatment ADC value of BRPC tumor
           in a largest diameter and the rate of tumor cell destruction.

        6. ADC Cut-off value which predict more than 50% and less than 10% in tumor cell
           destruction rate.

        7. The correlation between the ratio of posttreatment/pretreatment ADC value of BRPC tumor
           in a largest diameter and the ratio of posttreatment/pretreatment SUV max.

        8. ADC Cut-off value and SUV max cut-off value which predict survival time after surgery
           more than 2 years and less than 2 years.

        9. The comparison of the accuracy of prediction for pathological diagnosis at abutment site
           between the ratio of posttreatment/pretreatment ADC value and CT scan.

       10. Three correlation between high ADC value/low ADC value/the ratio of
           posttreatment/pretreatment ADC value and survival time after surgery.

       11. Three correlation between high ADC value/low ADC value/the ratio of
           posttreatment/pretreatment ADC value and decreasing rate of CA19-9 value.

       12. The correlation between tumor's limb sign in diffusion MRI and the rate of tumor cell
           destruction more than 10%.
    

Intervention name(s): diffusion-weighted MRI
Intervention type(s): Other
Intervention description(s): Diffusion MRI Patients undergo MRI within 3 weeks before start of neoadjuvant therapy/ 5 weeks after the last dose. The setting of MRI scans for b-values is 0, 50, 1000 s/mm2. The same MRI (the MRI system/scanner Intera Achieva 3.0T from Philips Medical Systems) in the independent institution is used for all patients analyzed on this study. The region of interest is determined by consensus between two experienced MR radiologists in a largest diameter based on images of abdominal CT scans avoiding the vascular area on the image of ADC map. The mean ADC values for each tumor are automatically calculated on the image of ADC map using a tomographic software program.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The coefficient of correlation (Peason's r) was r=0.625 in our pilot study in patients with
        borderline resectable pancreatic cancer. To comfirm the producibility, it is judged as bad
        if the result is less than 10% from our previous study,the correlation coefficient
        threshold is 0.56 or more. At the setting of 90%confidential interval as 0.2, the number of
        case is estimated as 28. Considering unexpected situation, 30 cases is enough to analyze
        the correlation.