Unique ID issued by UMIN | UMIN000029507 |
---|---|
Receipt number | R000033601 |
Scientific Title | Exploratory study of [18F]DiFA for cancer patients |
Date of disclosure of the study information | 2017/10/17 |
Last modified on | 2018/04/18 15:43:31 |
Exploratory study of [18F]DiFA for cancer patients
Exploratory study of [18F]DiFA
Exploratory study of [18F]DiFA for cancer patients
Exploratory study of [18F]DiFA
Japan |
cancer
Radiology |
Malignancy
NO
To evaluate the development concept of [18F]DiFA developed in Hokkaido University for cancer patients.
Safety,Efficacy
Exploratory
Phase I,II
To compare [18F]DiFA accumulation with [18F]FMISO accumulation to hypoxia region in tumor.
1)To clarify the presence or the absence, the type, the severity, and frequency of adverse effects and to assess the shift of laboratory test values by the administration of [18F]DiFA.
2)To estimate the optimum amount of radioactivity and imaging time of [18F]DiFA PET for cancer patient.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Diagnosis
Medicine |
[18F]FMISO
Dose: 320-400 MBq
Injected quantity: 5 mL (Maximum)
Administration method: Single intravenous dose
[18F]DiFA
Dose: 600-740 MBq
Injected quantity: 3 mL (Maximum)
Administration method: Single intravenous dose
20 | years-old | <= |
70 | years-old | > |
Male and Female
Patients diagnosed with cancer in a doctor's visit to Hokkaido University Hospital or in Hokkaido University Hospital stay.
Satisfy the following conditions;
(1)aged 20-70 years old at agreement acquisition.
(2)gave a written informed consent.
(3)diagnosed with cancer with clinical manifestation, clinical course, imaging, and histo-pathological examination.
(4)confirmed the lesion in CT, MRI or FDG-PET.
(1) Pregnant women, breast-feeding women, or women who may be pregnant.
(2)with hepatic or renal disease.
(3) Karnofsky performance status(KPS) under 40.
(4) an acute disease symptom (nausea, vomiting, fever, diarrhea) within 3 days before administering.
(5) a history of hypersensitivity for medical drugs.
(6) a participation in other clinical trials at present or within 6 months (180 days) before consent.
(7) diagnosed by [18F]DiFA-PET within 90 days before consent.
(8) a history of drug abuse or alcoholism.
(9) considered as inappropriate for this study.
10
1st name | |
Middle name | |
Last name | Tohru Shiga |
Hokkaido University, Graduate School of Medicine
Department of Nuclear Medicine
N15, W7, Kita-Ku, Sapporo
011-706-5152
tshiga@med.hokudai.ac.jp
1st name | |
Middle name | |
Last name | Tohru Shiga |
Hokkaido University, Graduate School of Medicine
N15, W7, Kita-Ku, Sapporo
+81-11-706-5152
011-706-5152
tshiga@med.hokudai.ac.jp
Hokkaido University Hospital
Japan Agency for Medical Research and Development
Japanese Governmental office
NO
北海道大学病院(北海道)
2017 | Year | 10 | Month | 17 | Day |
Unpublished
Completed
2017 | Year | 09 | Month | 27 | Day |
2017 | Year | 11 | Month | 06 | Day |
2017 | Year | 10 | Month | 11 | Day |
2018 | Year | 04 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033601
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |