UMIN-CTR Clinical Trial

Basic information
Public title	Prognostic value of FDG-PET radiomics with machine learning in pancreatic cancer
Acronym	Prognostic value of FDG-PET radiomics with machine learning in pancreatic cancer
Scientific Title	Prognostic value of FDG-PET radiomics with machine learning in pancreatic cancer
Scientific Title:Acronym	Prognostic value of FDG-PET radiomics with machine learning in pancreatic cancer
Region	Japan

Condition
Condition	Pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the utility of radiomics with machine learning using 18F-fluorodeoxyglucose (FDG)-PET in patients with pancreatic cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The study endpoint was overall survival (OS), defined as the time from pretreatment FDG-PET/CT scan to cancer-related death. Outcome data were collected from the medical records of each patient. Surviving patients were censored at the time of last clinical follow-up.
Key secondary outcomes

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	We enrolled 314 consecutive patients with biopsy-confirmed pancreatic invasive ductal carcinoma who underwent FDG-PET/CT before treatment between April 2010 and March 2018. 20 years old or older
Key exclusion criteria	The exclusion criteria were as follows: 1) no significant solid mass on CT/MRI; 2) no significant FDG-uptake; 3) uncontrolled diabetes (<150 mg/dl); 4) multiple cancer; 5) unknown clinical course; 6) under best supportive care; 7) sudden death; 8) early death after surgery.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Toyama
Organization	Tohoku University Hospital
Division name	Department of Diagnostic Radiology
Zip code	9808574
Address	1-1 Seiryo-Machi, Aoba-Ku, Sendai
TEL	+81-22-717-7312
Email	ytoyama0818@gmail.com

Public contact
Name of contact person	1st name Yoshitaka Middle name Last name Toyama
Organization	Tohoku University Hospital
Division name	Department of Diagnostic Radiology
Zip code	9808574
Address	1-1 Seiryo-Machi, Aoba-Ku, Sendai
TEL	+81-22-717-7312
Homepage URL
Email	ytoyama0818@gmail.com

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tohoku University Hospital IRB
Address	1-1 Seiryo-Machi, Aoba-Ku, Sendai
Tel	022-728-4105
Email	ytoyama0818@gmail.com

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	2020 Year 01 Month 29 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	161
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	Completed
Date of protocol fixation	2019 Year 07 Month 11 Day
Date of IRB	2019 Year 07 Month 26 Day
Anticipated trial start date	2019 Year 07 Month 11 Day
Last follow-up date	2019 Year 07 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

To obtain the volume of interest (VOI) of the primary tumor, a sphere was set to encompass the lesion and then contoured using a threshold of 40% of the SUVmax. A total of 42 PET parameters including conventional features (e.g., SUVmax, MTV, TLG) and global, local, and regional texture features were measured using the LIFEx package. Texture features were calculated only for VOIs of 64 voxels because textural features cannot be accurately quantified for small regions. All PET/CT images were assessed by two nuclear medicine physicians, with decisions made in consensus.

Management information
Registered date	2020 Year 01 Month 28 Day
Last modified on	2020 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044817