UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029343 |
|---|---|
| Receipt number | R000033503 |
| Scientific Title | Initial clinical evaluation of [18F]FSU-880, a PET probe targeting PSMA; safety, distribution, dosimetry and accumulation in prostate cancer. |
| Date of disclosure of the study information | 2017/12/25 |
| Last modified on | 2019/02/06 10:15:49 |
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Basic information
Public title
Initial clinical evaluation of [18F]FSU-880, a PET probe targeting PSMA; safety, distribution, dosimetry and accumulation in prostate cancer.
Acronym
Initial clinical evaluation of [18F]FSU-880, a PET probe targeting PSMA.
Scientific Title
Initial clinical evaluation of [18F]FSU-880, a PET probe targeting PSMA; safety, distribution, dosimetry and accumulation in prostate cancer.
Scientific Title:Acronym
Initial clinical evaluation of [18F]FSU-880, a PET probe targeting PSMA.
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety, distribution, dosimetry of [18F]FSU-880, a low molecular weight PET probe targeting PSMA that is highly expressed on prostate cancer cells, and to verify the accumulation of [18F]FSU-880 in prostate cancer tissue.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vital signs and blood and urine analysis data before and after administration of [18F]FSU-880.
Dosimetry calculation data based on serial change of [18F]FSU-880 distribution.
Qualitative and semi-quantitative uptake of [18F]FSU-880 in known prostate cancer tissue.
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
| Device,equipment |
Interventions/Control_1
Collect PET/CT data after intravenous administration of [18F]FSU-880 (approximately 185MBq)that is produced by automated synthetic device.
PET/CT data collection is finished in 1 day.
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
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Patients having metastatic/recurrent prostate cancer that is confirmed by pathological or imaging diagnosis.
2. Patients who are determined to be appropriate for this study by participating physicians according to the results of physical examination and blood/urine/physiological function tests.
3. Patients who give written informed consent on this study.
Key exclusion criteria
1. Patients having severe communication problem.
2. Patients with severe general condition.
3. Patients having severe renal dysfunction (eGFR<39mL/min/1.73m3) expected to affect the distribution of [18F]FSU-880..
4. Patients to whom participating physicians judged to be inappropriate for this study.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Togashi |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3760
ktogashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuneo Saga |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3760
Homepage URL
saga@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Diagnostic Radiology
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Address
Tel
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
| 2017 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 29 | Day |
Last modified on
| 2019 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033503
| 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 |
