Clinical trial NCT02777463: The Prediction Using Diffusion MRI of the Response Evaluation in BRPC in NAT.
Official title: The Prediction Using Diffusion-weighted MRI of the Response Evaluation in Borderline Resectable Pancreatic Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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%.

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

Primary outcomes:
measure: 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.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Secondary outcomes:
measure: The statistical analysis of the correlation between pretreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
measure: The statistical analysis of the correlation between posttreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
measure: 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.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
measure: The statistical analysis of the correlation between pretreatment ADC value of BRPC tumor in a largest diameter and the rate of tumor cell destruction.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
measure: 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.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
measure: 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.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
measure: 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.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
measure: 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.
timeFrame: Five years after initial therapy.
measure: 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.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
measure: Three correlation between high ADC value/low ADC value/the ratio of posttreatment/pretreatment ADC value and survival time after surgery.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
measure: 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.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
measure: The statistical analysis of the correlation between tumor's limb sign in diffusion MRI and the rate of tumor cell destruction more than 10%.
timeFrame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Other outcomes:
Locations:
city: Wakayama
country: Japan
facility: Wakayama Medical University
state: Wakayama Prefecture
Study officials:
References: