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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002652
Receipt No. R000003229
Scientific Title Imaging of hypoxia with [18F] fluoromisonidazole for cure limitation tissue and therapy strategy
Date of disclosure of the study information 2009/11/01
Last modified on 2018/06/11

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Basic information
Public title Imaging of hypoxia with [18F] fluoromisonidazole for cure limitation tissue and therapy strategy
Acronym FMISO-PET/CT clinical study
Scientific Title Imaging of hypoxia with [18F] fluoromisonidazole for cure limitation tissue and therapy strategy
Scientific Title:Acronym FMISO-PET/CT clinical study
Region
Japan

Condition
Condition Lung cancer, Breast cancer, Colon cancer, Head and neck cancer, Brain tumor, Pancreatic cancer, Malignant lymphoma, Malignant melanoma, Esophageal cancer, Endometrial cancer,uterine cervical cancer, ovarian cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Breast surgery Obsterics and gynecology
Dermatology Oto-rhino-laryngology Radiology
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate whether cure limitation detected by PET imaging using a hypoxia tracer [18F]fluoromisonidazole(FMISO) can be reduced in patient planned for radiotherapy and/or medication therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Tracer uptake in biphasic pairs of [18F]FMISO-PET/CT and [18F]FDG-PET/CT
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 FMISO-PET/CT
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with malignant tumor planned for radiotherapy and/or medication.
Key exclusion criteria Pregnancy or possibility of pregnancy
Patients regarded as unsuitable by responsible investigators
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiei Kuji
Organization Saitama International Medical Center, Saitama Medical University
Division name Department of Nuclear Medicine
Zip code
Address 1397-1 Yamane, Hidaka, Saitama
TEL 042-984-4147
Email kuji@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Clinical test assistant
Organization Saitama Medical University International Medical Center
Division name Clinical test assistant center
Zip code
Address 7-1 Yamane, Hidaka, Saitama
TEL 042-984-4111
Homepage URL
Email chikens@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical 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
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
2009 Year 11 Month 01 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
We evaluated a metabolic variation of tumors using positron  emission tomography. Various metabolic patterns were demonstrated in our studies, and these results should be useful for diagnosis and therapy of various malignant tumors. An early response to radiation and/or chemotherapy was evaluated based on tumor shrinkage using CT images. The FMISO uptake in the tumor had a negative correlation with the tumor shrinkage after therapy. FMISO may be a good predictive indicator for therapy. Breast cancer showed various metabolic patterns, which may correlate with the intrinsic subtypes.
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
2009 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 21 Day
Last modified on
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003229

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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