UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047509 |
|---|---|
| Receipt number | R000054182 |
| Scientific Title | Evaluation using FAPI-PET targeting cancer-associated fibroblasts |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2023/02/25 22:18:59 |
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Basic information
Public title
Evaluation using FAPI-PET targeting cancer-associated fibroblasts
Acronym
Evaluation using FAPI-PET
Scientific Title
Evaluation using FAPI-PET targeting cancer-associated fibroblasts
Scientific Title:Acronym
Evaluation using FAPI-PET
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
PET / CT examination using [18F] FAPI-74 injection is performed on patients diagnosed with malignant tumor, and the pathological condition is determined by comparing with CT and FDG-PET examination of conventional diagnostic imaging. Evaluate in detail
Basic objectives2
Others
Basic objectives -Others
Evaluation of the pathology in detail
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Comparison of the uptake on FAPI-PET with conventional imaging (CT and FDG-PET)
2) Comparison of pathological specimens obtained by surgery or biopsy with abnormal uptake on FAPI-PET
3) Time course of uptake on FAPI-PET before and after treatment compared with conventional imaging
Key secondary outcomes
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
Patients who meet any of the following conditions.
(1) Patients who have been diagnosed with malignant tumors or suspected of having malignant tumors and have CT or FDG-PET examination.
(2) Patients who have been diagnosed with malignant tumor and are scheduled to receive or have undergone anticancer treatment such as chemotherapy or radiation therapy.
(3) Patients suspected of recurrence by clinical findings or diagnostic imaging such as CT or FDG-PET after treatment of malignant tumor
Key exclusion criteria
(1) Pregnant women or patients who may be pregnant
(2) Pediatric patients requiring sedation
(3) Those who are judged to be inappropriate as subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watabe |
Organization
Osaka University Hospital
Division name
Department of Nuclear Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
TEL
06-6879-3461
watabe@tracer.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Watabe |
Organization
Osaka University Hospital
Division name
Department of Nuclear Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
TEL
06-6879-3461
Homepage URL
watabe@tracer.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital Institutional Review Board
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
| 2022 | Year | 05 | Month | 01 | 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
| 2022 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 17 | Day |
Last modified on
| 2023 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054182
