- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02777463
The Prediction Using Diffusion MRI of the Response Evaluation in BRPC in NAT. (DIFFERENT)
The Prediction Using Diffusion-weighted MRI of the Response Evaluation in Borderline Resectable Pancreatic Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
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.
- The correlation between pretreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.
- The correlation between posttreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.
- The correlation between the ratio of posttreatment/pretreatment ADC value at the abutment site of BRPC and the rate of tumor cell destruction.
- The correlation between pretreatment ADC value of BRPC tumor in a largest diameter and the rate of tumor cell destruction.
- The correlation between the ratio of posttreatment/pretreatment ADC value of BRPC tumor in a largest diameter and the rate of tumor cell destruction.
- ADC Cut-off value which predict more than 50% and less than 10% in tumor cell destruction rate.
- 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.
- 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.
- The comparison of the accuracy of prediction for pathological diagnosis at abutment site between the ratio of posttreatment/pretreatment ADC value and CT scan.
- Three correlation between high ADC value/low ADC value/the ratio of posttreatment/pretreatment ADC value and survival time after surgery.
- Three correlation between high ADC value/low ADC value/the ratio of posttreatment/pretreatment ADC value and decreasing rate of CA19-9 value.
- The correlation between tumor's limb sign in diffusion MRI and the rate of tumor cell destruction more than 10%.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Wakayama Prefecture
-
Wakayama, Wakayama Prefecture, Japan, 641-8510
- Wakayama Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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.
Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
|
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.
Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
|
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.
Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
|
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.
Time Frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
|
The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
|
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.
|
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 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.
|
The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
|
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.
|
Five years after initial therapy.
|
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.
|
The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
|
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.
|
The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
|
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.
|
The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
|
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.
|
The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADC-BRPC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Cancer
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CelgeneWithdrawnPancreatic Ductal Adenocarcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of NebraskaNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic Cancer | Stage I Pancreatic Cancer | Resectable Pancreatic Carcinoma | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)CompletedPancreatic Adenocarcinoma | Recurrent Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedPancreatic Adenocarcinoma | Resectable Pancreatic Cancer | Stage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer | Poorly Differentiated Malignant Neoplasm | Undifferentiated Pancreatic CarcinomaUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic Cancer
-
National Cancer Institute (NCI)CompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
University of UtahNovartis PharmaceuticalsRecruitingMetastatic Pancreatic Carcinoma | Unresectable Pancreatic Carcinoma | Stage III Pancreatic Cancer | Stage IV Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage II Pancreatic CancerUnited States
-
Shanghai Zhongshan HospitalFudan UniversityNot yet recruitingPancreatic Cancer Stage III | Pancreatic Cancer, Stage IB | Pancreatic Cancer, Stage IIA | Pancreatic Cancer, Stage IIBChina
-
University of Wisconsin, MadisonCompletedStage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IA Pancreatic Cancer | Stage IB Pancreatic CancerUnited States
-
Fudan UniversityUnknownStage ⅠA Pancreatic Cancer | Stage ⅠB Pancreatic Cancer | Stage ⅡA Pancreatic Cancer | Stage ⅡB Pancreatic CancerChina
Clinical Trials on diffusion-weighted MRI
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); University of Iowa; Oregon Health and Science... and other collaboratorsRecruiting
-
M.D. Anderson Cancer CenterRecruitingMetastatic Malignant Neoplasm in the Liver | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Resectable Colorectal CarcinomaUnited States
-
Universitaire Ziekenhuizen KU LeuvenUnknownRecurrence | Uterine Cervical Cancer | Diffusion-weighted MRIBelgium
-
American College of Radiology Imaging NetworkNational Cancer Institute (NCI)Completed
-
CHU de ReimsCompleted
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Ohio State University Comprehensive Cancer CenterWithdrawn
-
University of Michigan Rogel Cancer CenterCompletedBreast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedAdenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterU.S. Army Medical Research and Development Command; U.S. Army Medical Research...CompletedBreast Carcinoma | Malignant Breast Neoplasm | Benign Breast NeoplasmUnited States