The prediction using diffusion-weighted MRI of the response evaluation in unresectable pancreatic cancer in patients undergoing neoadjuvant therapy. A pilot study

The prediction using diffusion-weighted MRI of the response evaluation in unresectable pancreatic cancer in patients undergoing neoadjuvant therapy. A pilot study - the response evaluation in unresectable pancreatic cancer in patients undergoing neoadjuvant therapy. A pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000028030

Enrollment

Registered

2017-07-10

Start date

2017-08-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histopathologically diagnosed as pancreatic ductal adenocarcinoma or adenosquamous carcinoma by cytology, histological examination, or imaging study, and diagnosed as unresectable resectable pancreatic carcinoma (URPC) by MD-CT . 2.Measurable lesion is present. 3.Patients who undergo initial therapy. 4.Meet the definition of URPC in detail: Fulfill the definition of BRPC in NCCN guideline Version 2. 5.Metallic stent made of Nitinol is allowed to use for biliary drainage.

Exclusion criteria

Exclusion criteria: 1. Without severe drug allergy. 2. With history of malignant disease within 5 years. 3. Active stutus of infectious disease. 4. With metal in body which is contraindication for MRI. 5. With claustrophobia. 6. Incapability to collaborate in respiration. 7. The presence of uncontrollable ascites. 8. The presence of uncontrollable DM 9. The presence of uncontrollable CHD, angina, HTN, and arrhythmia. 10. The presence of severe neurological, psychological disease or their history.

Design outcomes

Primary

Measure	Time frame
The correlation between pretreatment ADC value of diffusion MRI and pathologic response evaluated by Evans grade in patients with unresectable pancreatic carcinoma (URPC) who undergo neoadjuvant therapy.	—

Secondary

Measure	Time frame
1. The correlation between pretreatment ADC value at the abutment site of URPC and the rate of tumor cell destruction. 2. The correlation between posttreatment ADC value at the abutment site of URPC and the rate of tumor cell destruction. 3.The correlation between the ratio of posttreatment/pretreatment ADC value at the abutment site of URPC and the rate of tumor cell destruction. 4.The correlation between pretreatment ADC value of URPC 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 URPC 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%.	—

Measure

Time frame

1. The correlation between pretreatment ADC value at the abutment site of URPC and the rate of tumor cell destruction. 2. The correlation between posttreatment ADC value at the abutment site of URPC and the rate of tumor cell destruction. 3.The correlation between the ratio of posttreatment/pretreatment ADC value at the abutment site of URPC and the rate of tumor cell destruction. 4.The correlation between pretreatment ADC value of URPC 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 URPC 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%.

—

Countries

Japan

Contacts

Public ContactKen-ichi Okada

Wakayama Medical University Second Department of Surgery

okada@wakayama-med.ac.jp073-441-0613

Outcome results