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Clinical Trial 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.


Clinical Trial 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%. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02777463
Study type Observational [Patient Registry]
Source Wakayama Medical University
Contact
Status Completed
Phase
Start date June 2016
Completion date January 2020

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