UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005850 |
|---|---|
| Receipt number | R000006912 |
| Scientific Title | Molecular imaging of DNA synthesis: Diagnosis of cancer using a new PET tracer |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2019/03/18 19:22:05 |
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Basic information
Public title
Molecular imaging of DNA synthesis: Diagnosis of cancer using a new PET tracer
Acronym
4'-[methyl-11C]thiotymidine(4DST)PET for cancer diagnosis
Scientific Title
Molecular imaging of DNA synthesis: Diagnosis of cancer using a new PET tracer
Scientific Title:Acronym
4'-[methyl-11C]thiotymidine(4DST)PET for cancer diagnosis
Region
| Japan |
Condition
Condition
Lung cancer
Multiple myeloma
Esophageal cancer
Head and neck caner
Classification by specialty
| Gastroenterology | Cardiology | Pneumology |
| Hematology and clinical oncology | Gastrointestinal surgery | Chest surgery |
| Oto-rhino-laryngology | Radiology | Cardiovascular surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of 4DST-PET for diagnosis and therapy evaluation of cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
As a surrogate marker of tumor proliferation and of therapeutic response, 4DST-PET could be superior than FDG-PET.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
4DSTPET and FDGPET in a same patient will be compared to the pathology or to the clinical golden standards.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient who is pathologically diagnosed as malignancy.
2.Age: >20 years.
3. Capability to have PET scan.
4. Completed the written informed consent
Key exclusion criteria
1. Unable to have signed informed consent.
2.Patient with severe underlying disease having risk of liver dysfunction, renal dysfunction and any metabolic damage.
3. Just after surgery and/or trauma
4. Uncontrollable diabetics
5. Those who are determined as not appropriate for the study by physician in chief.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryogo Minamimoto |
Organization
National Center for Global Health and Medicine
Division name
Department of Radiology, Division of Nuclear Medicine
Zip code
Address
1-21-1, Toyama, Shinjyuku-ku, Tokyo
TEL
03-3202-7181
rminamimoto@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryogo Minamimoto |
Organization
National Center for Global Health and Medicine
Division name
Department of Radiology, Division of Nuclear Medicine
Zip code
Address
1-21-1, Toyama, Shinjyuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
rikensa@lily.ocn.ne.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Metropolitan Institute for Gerontology
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
国立国際医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We compared the maximum standardized uptake value (SUVmax) of lung tumors on both 11C-4DST and 18F-FDG PET/CT with the Ki-67 index of cellular proliferation and with CD31-positive vessels as a marker of angiogenesis in surgical pathology. The correlation coefficient between SUVmax and Ki-67 index was higher with 11C-4DST (r = 0.82) than with 18F-FDG (r = 0.71). That with CD31 was low for both tracers. 11C-4DST PET/CT may allow noninvasive imaging of DNA synthesis in NSCLC.
Minamimoto R, st al. J Nucl Med 2012;53:199-206.
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
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
FDG uptake by tumor tissue, 4DST uptake by tumor tissue, MIB-1 index by immuno-staining of Ki-67 of resected tumor tissue, histopathological type, these informations will be compared.
Management information
Registered date
| 2011 | Year | 06 | Month | 26 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006912
| 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 |
