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

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ClinicalTrials.gov Identifier: NCT02777463
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Hiroki Yamaue, Wakayama Medical University

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.

Condition or disease Intervention/treatment
Pancreatic Cancer Other: diffusion-weighted MRI

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%.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Prediction Using Diffusion-weighted MRI of the Response Evaluation in Borderline Resectable Pancreatic Cancer.
Actual Study Start Date : June 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  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. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]

Secondary Outcome Measures :
  1. The statistical analysis of the correlation between pretreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]
  2. The statistical analysis of the correlation between posttreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]
  3. 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. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]
  4. The statistical analysis of the correlation between pretreatment ADC value of BRPC tumor in a largest diameter and the rate of tumor cell destruction. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]
  5. 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. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]
  6. 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. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]
  7. 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. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]
  8. 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. [ Time Frame: Five years after initial therapy. ]
  9. 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. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]
  10. Three correlation between high ADC value/low ADC value/the ratio of posttreatment/pretreatment ADC value and survival time after surgery. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]
  11. 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. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]
  12. The statistical analysis of the correlation between tumor's limb sign in diffusion MRI and the rate of tumor cell destruction more than 10%. [ Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months. ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria
The patients with borderline resectable pancreatic cancer who is expexted to undergo neoadjuvant therapy and subsequent radical surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777463


Contacts
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Contact: Ken-ichi Okada, M.D., Ph.D. +81-73-441-0613 ext 5112 okada@wakayama-med.ac.jp

Locations
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Japan
Wakayama Medical University Recruiting
Wakayama, Wakayama Prefecture, Japan, 641-8510
Sponsors and Collaborators
Wakayama Medical University

Additional Information:

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Responsible Party: Hiroki Yamaue, Second Department of Surgery, Wakayama Medical University, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT02777463     History of Changes
Other Study ID Numbers: ADC-BRPC
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: December 2018
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases