UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028332 |
|---|---|
| Receipt number | R000032427 |
| Scientific Title | Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole |
| Date of disclosure of the study information | 2017/07/24 |
| Last modified on | 2023/01/25 09:51:25 |
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Basic information
Public title
Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole
Acronym
Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole
Scientific Title
Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole
Scientific Title:Acronym
Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change of tumor hypoxia in lung cancer using 18F-fluoromisonidazole after stereotactic radiotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of 18F-MISO uptake between before and after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
To perform F-MISO PET/CT before and 1 day after treatment
Interventions/Control_2
To perform F-MISO PET/CT before and 2 day after treatment
Interventions/Control_3
To perform F-MISO PET/CT before and 3 day after treatment
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 and Female
Key inclusion criteria
1)Adaptable of stereotactic radiotherapy for primary or metastatic lung malignant tumor less of equal 5cm. Fulfilling both of the following conditions and clinically diagnosed as NSCLC.
a) increase in tumor size of 1 mm or more, or consolidation/tumor ratio turning >50% from <=50% on CT scans performed 28 days or more apart.
b) positive accumulation on FDG-PET.
2)Performance status (ECOG): 0-2
3)Enable for performing PET/CT
4)Aged 20 to 84
5)signed informed consent
Key exclusion criteria
1)During the pregnancy or a pregnant female patient we are possible or are nursing.
2)The patient whom we merge psychosis or neurological manifestation, and it is judged to have difficulty with participation to an examination.
3)Severe complications whom enable to perform PET/CT
4)Other reasons with inadequate to enroll this trial
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Nishimura |
Organization
Kindai University
Division name
Department of Radiation Oncology,
Zip code
5898511
Address
377-2,ohnohigashi,osakasayamashi,osaka
TEL
072-366-0221
im022012@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Inada |
Organization
Kindai University
Division name
Department of Radiation Oncology,
Zip code
5898511
Address
377-2,ohnohigashi,osakasayamashi,osaka
TEL
072-366-0221
Homepage URL
im022012@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
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
Kindai Univarsity Faclty of medicine
Address
Ohnohigashi 377-2, Osakasayama city, Osaka
Tel
0723880221
im022012@med.kindai.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
| 2017 | Year | 07 | Month | 24 | 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
15
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
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032427
