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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028030
Receipt No. R000032096
Scientific Title The prediction using diffusion-weighted MRI of the response evaluation in unresectable pancreatic cancer in patients undergoing neoadjuvant therapy. A pilot study
Date of disclosure of the study information 2017/07/10
Last modified on 2019/07/03

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Basic information
Public title The prediction using diffusion-weighted MRI
of the response evaluation in unresectable pancreatic cancer
in patients undergoing neoadjuvant therapy. A pilot study
Acronym the response evaluation in unresectable pancreatic cancer in patients undergoing neoadjuvant therapy. A pilot study
Scientific Title The prediction using diffusion-weighted MRI
of the response evaluation in unresectable pancreatic cancer
in patients undergoing neoadjuvant therapy. A pilot study
Scientific Title:Acronym the response evaluation in unresectable pancreatic cancer in patients undergoing neoadjuvant therapy. A pilot study
Region
Japan

Condition
Condition Pancreatic carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the correlation between pretreatment ADC value of diffusion MRI and pathologic response in patients with unresectable pancreatic carcinoma who undergo neoadjuvant therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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.
Key secondary outcomes 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%.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.

Key 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.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Ken-ichi
Middle name
Last name Okada
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address Kimiidera 811-1, Wakayama City
TEL 073-441-0613
Email okada@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Ken-ichi
Middle name
Last name Okada
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address Kimiidera 811-1, Wakayama City
TEL 073-441-0613
Homepage URL
Email okada@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Wakayama Medical University
Address 811-1 Kimiidera, Wakayama City
Tel 0734472300
Email warinri@wakayama-med.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 5
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 05 Month 19 Day
Date of IRB
2017 Year 08 Month 09 Day
Anticipated trial start date
2017 Year 08 Month 10 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design:
Single institution, a Pilot study, single arm.

Management information
Registered date
2017 Year 07 Month 01 Day
Last modified on
2019 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032096

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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