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

NCT02777463 | Completed DMC

• 1 other identifier: ADC-BRPC
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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.

• 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.

• 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.

• 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.

• 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.

Interventions

diffusion-weighted MRI OTHER

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.

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wakayama Medical University: lead

Study Sites (1)

Wakayama Medical University

Wakayama, Wakayama, 641-8510, Japan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Second Department of Surgery, Wakayama Medical University

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 19, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

JP (1)