UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028030 |
|---|---|
| Receipt number | 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 | 2023/01/05 18:52:22 |
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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
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
okada@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
https://pubmed.ncbi.nlm.nih.gov/31993737/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31993737/
Number of participants that the trial has enrolled
28
Results
Pre/post-treatment whole tumor ADC value correlated with tumor cell destruction rate among all parameters (R=0.630/0.714, P<0.001/<0.0001). The post-treatment cutoff value of vascular abut site ADC for discriminating between grade<IIb and >=grade IIb was determined as 1.42x10-3 mm2/s and predicts R0 curability. For histological response, the post-treatment whole tumor ADC cutoff value for discriminating between grade<IIb and >= grade IIb was determined as 1.40x10-3 mm2/s.
Results date posted
| 2023 | Year | 01 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
We prospectively reviewed 28 patients with BRPC or LAPC who underwent diffusion-weighted magnetic resonance imaging before neoadjuvant chemotherapy and surgery.
Participant flow
Patients were enrolled after the diagnoses of borderline resectable pancreatic cancer. We elucidate correlation between pre/post-treatment whole tumor apparent diffusion coefficient (ADC) value and tumor cell destruction rate. We verify whether post-treatment vascular abut site ADC value predicts R0 curability of borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC).
Adverse events
None
Outcome measures
We elucidate correlation between pre/post-treatment whole tumor apparent diffusion coefficient (ADC) value and tumor cell destruction rate. We verify whether post-treatment vascular abut site ADC value predicts R0 curability of borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC). Analyses for correlation between percent tumor cell destruction and various parameters were performed. Strong parameters were assessed for ability to predict therapeutic histological response and R0 curability.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032096
