UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Imaging of hypoxia with [18F] fluoromisonidazole for cure limitation tissue and therapy strategy
Title of the study (Brief title)	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	Ichiei Kuji
Organization	Saitama International Medical Center, Saitama Medical University
Division name	Department of Nuclear Medicine
Address	1397-1 Yamane, Hidaka, Saitama
TEL	042-984-4147
Email	kuji@saitama-med.ac.jp

Public contact
Name of contact person	Clinical test assistant
Organization	Saitama Medical University International Medical Center
Division name	Clinical test assistant center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 10 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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