UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052534 |
|---|---|
| Receipt number | R000059754 |
| Scientific Title | Pathophysiological assessment by FAPI-PET targeting cancer-associated fibroblasts in proton therapy |
| Date of disclosure of the study information | 2023/10/18 |
| Last modified on | 2023/10/18 14:03:49 |
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Basic information
Public title
Pathophysiological assessment by FAPI-PET targeting cancer-associated fibroblasts in proton therapy
Acronym
Pathophysiological assessment by FAPI-PET in proton therapy
Scientific Title
Pathophysiological assessment by FAPI-PET targeting cancer-associated fibroblasts in proton therapy
Scientific Title:Acronym
Pathophysiological assessment by FAPI-PET in proton therapy
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
PET/CT examinations using the PET tracer [18F]-FAPI-74 injection performed on patients diagnosed with malignant tumors before and after proton therapy, and compared with conventional imaging (CT and FDG-PET) to evaluate the tumor control status after proton therapy in detail
Basic objectives2
Others
Basic objectives -Others
Pathophysiological assessment in detail
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Qualitative and quantitative evaluation of FAPI-PET images
Key secondary outcomes
Qualitative evaluation of CT and 18F-FDG PET images and comparison with quantitative evaluation indices
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
PET examination
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients scheduled to receive proton therapy for malignant tumors of the lung, hepatobiliary pancreas, digestive organs, and bone and soft tissue
(2) Patients who have the ability to understand and comply with the contents of this study
(3) Patients who can obtain written consent from the subjects themselves.
Key exclusion criteria
(1) Pregnant women, lactating women, and women who may be pregnant
(2) Pediatric patients who require sedation
(3) Patients whom the principal investigator or co-investigators deem inappropriate to conduct this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsuda |
Organization
Southern Tohoku Research Institute for Neuroscience
Division name
Drug Discovery and Cyclotron Research Center
Zip code
963-8052
Address
7-61-2, Yatsuyamada, Koriyama, Fukushima
TEL
024-934-5610
hiroshi.matsuda@mt.strins.or.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsuda |
Organization
Southern Tohoku Research Institute for Neuroscience
Division name
Drug Discovery and Cyclotron Research Center
Zip code
963-8052
Address
7-61-2, Yatsuyamada, Koriyama, Fukushima
TEL
024-934-5610
Homepage URL
hiroshi.matsuda@mt.strins.or.jp
Sponsor or person
Institute
Southern Tohoku Research Institute for Neuroscience
Institute
Department
Personal name
Funding Source
Organization
Southern Tohoku Research Institute for Neuroscience
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Southern Tohoku Research Institute for Neuroscience
Address
7-115, Yatsuyamada, Koriyama, Fukushima
Tel
024-934-5322
rinri@mt.strins.or.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 | 10 | Month | 18 | 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 | 08 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 21 | 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 | 10 | Month | 18 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059754
| Research Plan | |
|---|---|
| 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 |
