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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000028332 |
Receipt No. | 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 | 2019/07/24 |
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 |
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Condition | ||
Condition | Lung cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 18 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Kindai University |
Institute | |
Department |
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 |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032427 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |