UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002652 |
|---|---|
| Receipt number | 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 09:31:58 |
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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 | Obstetrics 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
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
chikens@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003229
