UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055555 |
|---|---|
| Receipt number | R000063049 |
| Scientific Title | Initial Investigation of 18F-FAPI-74 PET for Evaluating Hepatocellular Carcinoma Before and After Systemic Pharmacotherapy |
| Date of disclosure of the study information | 2024/09/20 |
| Last modified on | 2024/09/20 10:44:37 |
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Basic information
Public title
Evaluation of a Novel PET Imaging Method for Assessing Liver Cancer Treatment Response
Acronym
Liver Cancer FAPI-PET Study
Scientific Title
Initial Investigation of 18F-FAPI-74 PET for Evaluating Hepatocellular Carcinoma Before and After Systemic Pharmacotherapy
Scientific Title:Acronym
HCC FAPI-PET Evaluation Study
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate hepatocellular carcinoma before and after systemic drug therapy using 18F-FAPI-74 PET, and compare it with RECIST and mRECIST criteria. By assessing the disease state of hepatocellular carcinoma before and after systemic therapy using 18F-FAPI-74 PET, there is potential for application in future diagnosis, treatment, and prognosis evaluation. This study is expected to provide fundamental data for future confirmatory clinical research.
Basic objectives2
Others
Basic objectives -Others
Evaluating pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the rate of change in 18F-FAPI-74 PET quantitative values for each lesion and treatment response assessment by RECIST and mRECIST criteria
Key secondary outcomes
1. Correlation between the rate of change in 18F-FAPI-74 PET quantitative values and the rate of change in tumor markers (AFP, PIVKA-II)
2. Comparison of pre-treatment 18F-FAPI-74 PET/CT imaging findings with those of contrast-enhanced CT and MRI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
The intervention in this study is PET/CT imaging using ^18^F-FAPI-74. This imaging technique is performed on patients with hepatocellular carcinoma before and after systemic drug therapy. Specifically, the radioactive tracer ^18^F-FAPI-74 is administered intravenously, followed by whole-body imaging using a PET/CT scanner. The intervention is conducted in a single group, with each patient undergoing the same procedure twice - once before treatment and once after treatment.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 18 years or older at the time of consent
Diagnosed with hepatocellular carcinoma and scheduled for systemic drug therapy
Consent to the use of 18F-FAPI-74 PET results in clinical practice if deemed necessary by the attending physician
Ability to provide written informed consent
Key exclusion criteria
Pregnant women or those who may be pregnant
Individuals with severe claustrophobia
Individuals deemed unsuitable for participation in this study by the principal investigator or co-investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Yamane |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Molecular Imaging Research
Zip code
6500047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
TEL
0783024321
tomohiko_yamane@kcho.jp
Public contact
Name of contact person
| 1st name | Shojiro |
| Middle name | |
| Last name | Oka |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Diagnostic Radiology
Zip code
6500047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
TEL
0783024321
Homepage URL
shojiro511@gmail.com
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe City Medical Center General Hospital
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
Kobe City Medical Center General Hospital Research Ethics Committee
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
Tel
078-302-5176
rinken@kcho.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
| 2024 | Year | 09 | Month | 20 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063049
