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NCT Number: NCT02777463

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

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.

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Key information

Conditions

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

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wakayama Medical University

Wakayama, 641-8510, Japan

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Sponsors and collaborators

Lead sponsor

Wakayama Medical University

Other

Registry information

Official study title

The Prediction Using Diffusion-weighted MRI of the Response Evaluation in Borderline Resectable Pancreatic Cancer.

Acronym: DIFFERENT

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 19, 2016
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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