UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051687 |
|---|---|
| Receipt number | R000058594 |
| Scientific Title | Preliminary study evaluating the pathogenesis of malignant tumors using 18F-FAPI-74 PET |
| Date of disclosure of the study information | 2023/07/24 |
| Last modified on | 2023/08/17 08:27:18 |
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Basic information
Public title
Preliminary study evaluating the pathogenesis of malignant tumors using 18F-FAPI-74 PET
Acronym
FAPIONCO1
Scientific Title
Preliminary study evaluating the pathogenesis of malignant tumors using 18F-FAPI-74 PET
Scientific Title:Acronym
FAPIONCO1
Region
| Japan |
Condition
Condition
Malignant tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Endocrinology and Metabolism | Hematology and clinical oncology | Nephrology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology | Dermatology | Oto-rhino-laryngology |
| Urology | Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pathophysiology of various types of malignant tumors by visualizing cancer-associated fibroblasts using 18F-FAPI-74 PET/CT
Basic objectives2
Others
Basic objectives -Others
Evaluating pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Uptake difference of 18F-FAPI-74 PET/CT for the organ, lesion, or pathological status
Key secondary outcomes
1. Difference in lesion uptake between 18F-FAPI-74 PET/CT and 18F-FDG PET/CT
2. Relationship between 18F-FAPI-74 PET/CT uptake and specific tumor markers for each malignancy
3. Optimal acquisition time of 18F-FAPI-74 PET/CT
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
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
18F-FAPI PET/CT
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
1. Those who are 18 years of age or older at the time of consent
2. Those who have been diagnosed with or are strongly suspected of having a malignant tumor
3. Those who can give consent for the results of 18F-FAPI-74 PET to be used for medical treatment if deemed necessary by the attending physician
4. Those who can obtain written consent
Key exclusion criteria
1. Those who are or may be pregnant
2. Those who are with severe claustrophobia
3. Those who are considered to be inappropriate to participate in this study by the principal investigator or sub-investigator
Target sample size
80
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
650-0047
Address
Minatojima-Minamimachi 2-1-1, Chuo-Ku, Kobe
TEL
078-302-4321
tomohiko_yamane@kcho.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Yamane |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Molecular Imaging Research
Zip code
650-0047
Address
Minatojima-Minamimachi 2-1-1, Chuo-Ku, Kobe
TEL
078-302-4321
Homepage URL
https://chuo.kcho.jp/department/molecular_imaging_research/
tomohiko_yamane@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Katakami Foundation For Clinical Research, KBIC Research Grants-in-Aid for Clinical Research Promotion, Self-funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
Minatojima-Minamimachi 2-1-1, Chuo-ku, Kobe
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
| 2023 | Year | 07 | Month | 24 | 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
| 2023 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 07 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058594
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
