The Prediction Using Diffusion MRI of the Response Evaluation in BRPC in NAT.

Pancreatic Cancer Clinical Trial

— DIFFERENT  

Official title:

The Prediction Using Diffusion-weighted MRI of the Response Evaluation in Borderline Resectable Pancreatic Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777463
• Other study ID #: ADC-BRPC
• Status: Completed
• Start date: June 2016
• Est. completion date: January 2020

Study information

• Verified date: May 2020
• Source: Wakayama Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

The patients with borderline resectable pancreatic cancer who is expexted to undergo neoadjuvant therapy and subsequent radical surgery.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• diffusion-weighted MRI
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.

Locations

Country	Name	City	State
Japan	Wakayama Medical University	Wakayama	Wakayama Prefecture

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The statistical analysis of 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.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary	The statistical analysis of the correlation between pretreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary	The statistical analysis of the correlation between posttreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary	The statistical analysis of the correlation between the ratio of posttreatment/pretreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary	The statistical analysis of the correlation between pretreatment ADC value of BRPC tumor in a largest diameter and the rate of tumor cell destruction.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary	The statistical analysis of the correlation between the ratio of posttreatment/pretreatment ADC value of BRPC tumor in a largest diameter and the rate of tumor cell destruction.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary	The statistical analysis by ROC curve to investigate ADC Cut-off value which predict more than 50% and less than 10% in tumor cell destruction rate.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary	The statistical analysis of 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 in PET-CT.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary	The statistical analysis by ROC curve to investigate 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.		Five years after initial therapy.
Secondary	The statistical analysis of the comparison of the accuracy of prediction for pathological diagnosis at abutment site between the ratio of posttreatment/pretreatment ADC value and CT scan.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary	Three correlation between high ADC value/low ADC value/the ratio of posttreatment/pretreatment ADC value and survival time after surgery.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary	The statistical analysis of the correlation between high ADC value/low ADC value/the ratio of posttreatment/pretreatment ADC value and decreasing rate of CA19-9 value.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary	The statistical analysis of the correlation between tumor's limb sign in diffusion MRI and the rate of tumor cell destruction more than 10%.		The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.