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CompletedNCT02777463DIFFERENTUpdated May 20, 2020

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

An observational study in Pancreatic Cancer, sponsored by Wakayama Medical University. Completed at 1 site in Japan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-05-20.

Sponsored by Wakayama Medical University · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
28
Ages
20 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies in Pancreatic Neoplasms by Wakayama Medical University — none open to participants now, none under way, none of them phase 3. Pancreatic Neoplasms · Wakayama Medical University.

Started
2016
with 1 other
Observational
Only one
of the 10
Registered
9th of 10
by date

Among the 10 studies in Pancreatic Neoplasms by Wakayama Medical University, this one is one of 2 that started in 2016, is the only observational one, and was the 9th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

None of the 10 studies in Pancreatic Neoplasms by Wakayama Medical University is open now. The open studies under Pancreatic Neoplasms, anywhere →

Where they have run

Who these studies take

Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 20 Years to 85 Years · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 10 studies in Pancreatic Neoplasms by Wakayama Medical University as a file.
02

Study 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 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.

  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%.
03

Conditions studied

  • Pancreatic Cancer
04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
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.

Eligibility criteria

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
28 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • Otherdiffusion-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.

06

What researchers measure

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.

    Time frame: The time duration of examinations between pretreatment diffusion MRI and histopathological examination is approximately 4 months.

Secondary outcomes

  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.

07

Study locations

1 site
  • Wakayama Medical University
    Wakayama, Wakayama Prefecture 641-8510, Japan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in Jan 2020, 43 months.

Of 318 non-industry observational studies under Pancreatic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 182. This study's 43 months is below that.

Counting every sponsor, half of 352 studies reached it within 60 months; a quarter within 34 and three quarters within 182.

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2016
First posted
May 19, 2016
StartActual
Jun 2016
Primary completionActual
Jan 2020
CompletionActual
Jan 2020
Last update
May 20, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02777463
Lead sponsor
Wakayama Medical University
Responsible party
Hiroki Yamaue (Second Department of Surgery, Wakayama Medical University, Wakayama Medical University) — Principal investigator
First posted
May 19, 2016
Start date
Jun 2016
Primary completion
Jan 2020
Completion
Jan 2020
Last update
May 20, 2020

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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