Pancreatic CancerDIFFERENTNCT02777463
The Prediction Using Diffusion MRI of the Response Evaluation in BRPC in NAT.
An observational study of Pancreatic Cancer, run by Wakayama Medical University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- diffusion-weighted MRI
- How many people
- 28 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2016to Jan 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prediction Using Diffusion-weighted MRI of the Response Evaluation in Borderline Resectable Pancreatic Cancer.
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.
Read the 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%.
- Conditions
- Pancreatic Cancer
- Being tested
- diffusion-weighted MRI
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion-weighted MRIOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Wakayama Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiroki Yamaue, Wakayama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777463
- Sponsor's protocol ID
- ADC-BRPC
- Acronym
- DIFFERENT
- Status last verified
- May 2020
- First submitted
- 11 May 2016
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction Using Diffusion-weighted MRI of the Response Evaluation in Borderline Resectable Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT02777463
- Acronym / sponsor ID
- DIFFERENT / ADC-BRPC
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wakayama Medical UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diffusion-weighted MRIDiffusion 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. | Other | – |
Primary outcome
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.
12 secondary outcomes
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 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 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 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 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 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 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 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.
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.
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 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
Related trials for Pancreatic Cancer
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1/2
Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers
Pancreatic Cancer, Renal Cell Cancer
RecruitingObservational study
Pancreatic Cancer Early Detection Consortium
Pancreas Cancer, Pancreas Cyst
Active, not recruitingPhase 2
Redefining FOLFIORINOX in Older Pancreatic Cancer Patients
Metastatic Pancreatic Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Wakayama Medical University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020; AzTrials last refreshed its copy on 30 Oct 2026.