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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029343
Receipt No. 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

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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
Email 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
Email saga@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Diagnostic Radiology
Kyoto University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033503

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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