UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012322 |
|---|---|
| Receipt number | R000014407 |
| Scientific Title | Early evaluation for chemotherapy response of lung cancer using a new PET/CT tracer of DNA synthesis. |
| Date of disclosure of the study information | 2013/11/24 |
| Last modified on | 2017/05/22 09:04:37 |
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Basic information
Public title
Early evaluation for chemotherapy response of lung cancer using a new PET/CT tracer of DNA synthesis.
Acronym
4DST PET/CT for lung cancer chemotherapy
Scientific Title
Early evaluation for chemotherapy response of lung cancer using a new PET/CT tracer of DNA synthesis.
Scientific Title:Acronym
4DST PET/CT for lung cancer chemotherapy
Region
| Japan |
Condition
Condition
Non-small cell lung caner
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study the diagnostic utility of 4DST PET/CT, as a marker for DNA synthesis, for the early evaluation of chemotherapy response of lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
If the tumor uptake reduction of 4DST after chemotherapy is larger and earlier than that of FDG or not.
Key secondary outcomes
The correlation of the tumor uptake reductions of 4DST or FDG after chemotherapy and the tumor volume reduction, and the progression free survival.
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
Before and early after chemotherapy, both FDGPET/CT and 4DST PET/CT will be performed and compared to the clinical parameters. 4DSTPET/CT will be imaged 40min after injection, and FDGPET/CT 1hr after.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients having pathological diagnosis of non-small cell lung cancer, of which stage 3B or 4, or recurrence after surgery. And of whom performance status is 0 or 1, and having enough good hematological and biochemical data tolerable for chemotherapy. And those who have signed the informed consent form.
Key exclusion criteria
Those who have not signed the informed consent form.
Those who have symptomatic brain metastasis, or active double cancer, or active infectious disease, or spinal metastasis that required immediate surgery or radiotherapy, or uncontrollable hypertension, or ischemic heart disease, or uncontrollable diabetes.
Those who have been decided not appropriate by the physician.
Target sample size
80
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
Div.Nuclear Medicine, Dept.Radiology
Zip code
Address
1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
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
Div.Nuclear Medicine, Dept.Radiology
Zip code
Address
1-21-1 Shinjuku-ku Tokyo, 162-8655 Japan
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
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
| 2013 | Year | 11 | Month | 24 | 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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 17 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014407
| 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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