UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027712 |
|---|---|
| Receipt number | R000031745 |
| Scientific Title | Validation study of 3D-thoracic duct scintigraphy by orally administered 123I BMIPP with healthy subjects. |
| Date of disclosure of the study information | 2017/06/14 |
| Last modified on | 2021/02/10 14:06:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Validation study of 3D-thoracic duct scintigraphy by orally administered 123I BMIPP with healthy subjects.
Acronym
Validation study of 3D-thoracic duct scintigraphy
Scientific Title
Validation study of 3D-thoracic duct scintigraphy by orally administered 123I BMIPP with healthy subjects.
Scientific Title:Acronym
Validation study of 3D-thoracic duct scintigraphy
Region
| Japan |
Condition
Condition
Chylothorax
Classification by specialty
| Surgery in general | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to validate the three-dimensional (3D) thoracic duct scintigraphy using orally-administered I-123 BMIPP for the visualization of thoracic duct as a basis study for the clinical application for chylothorax.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of the time the drug passes through the stomach after administration of radiopharmaceutical, the time until the thoracic duct is depicted, and the time until the systemic circulation is visualized.
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
After orally administeration of radioactive pharmaceuticals, I-123 BMIPP, drug dynamics is tracked with a gamma camera.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Currently not visiting a hospital
(2)No history of chest and abdominal surgery
(3)Male and female aged 20 years and over when acquiring consent
(4)Accept written oral and written explanation about participation in research and agree on written agreement
Key exclusion criteria
(1)Difficulty fasting from the night inspection the day before
(2)Allergic to iodine or milk
(3)Severe back pain
(4)Possible pregnancy, during pregnancy, within 28 days after birth, or nursing
(5)Aspiration, impaired passage of gastrointestinal tract
(6)Difficult to climb up and down stairs
(7)Mental psychosis or psychiatric symptoms
(8)Judging undesirable as the subject of this study by the doctor
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Takanami |
Organization
Tohoku University Hospital
Division name
Department of Diagnostic Radiology
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Miyagi, Japan
TEL
022-717-7312
takanami@rad.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Takanami |
Organization
Tohoku University Hospital
Division name
Department of Diagnostic Radiology
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Miyagi, Japan
TEL
022-717-7312
Homepage URL
takanami@rad.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Reserchm Innovation and Education Center, Tohoku University Hospital
Address
1-1 Seiryo-cho, Aoba-ku, Miyagi, Japan
Tel
022-717-7122
trc@trc.med.tohoku.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
| 2017 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/report/KAKENHI-PROJECT-16K10701/16K107012019jisseki/
Publication of results
Published
Result
URL related to results and publications
https://kaken.nii.ac.jp/report/KAKENHI-PROJECT-16K10701/16K107012019jisseki/
Number of participants that the trial has enrolled
6
Results
A total of six healthy subjects were orally administered a long-chain fatty acid 15-(4-iodophenyl)-3(R,S)-methylpentadecanoic acid (BMIPP) encapsulated in double gelatin capsules and imaged with a gamma camera to evaluate the safety of the test and the ability to delineate the thoracic duct (TD). In all cases, TDs was clearly visible and the increase in radiation dose was slight compared to the intravenous administration. It was confirmed that 3D TD scintigraphy can be performed safely.
Results date posted
| 2021 | Year | 02 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eligibility Criteria
(1) Not currently attending a hospital
(2) No history of thoracic or abdominal surgery
(3) Male or female, 20 years of age or older at the time of obtaining consent
(4) Have received verbal and written explanations about participation in the study and have given written consent
Exclusion criteria
(1) Difficulty in fasting from the night before the test
(2) Iodine allergy or milk allergy
(3) Inability to sit still on the back for 10-30 minutes due to back pain, etc.
(4) Women who are pregnant, may become pregnant, within 28 days of childbirth, or are breastfeeding
(5) Has aspiration or dyspepsia
(6) Difficulty in climbing up the stairs to the bed of the diagnostic imaging system
(7) Complicated psychosis or psychiatric symptoms that make it difficult to participate in the study.
(8) The physician in charge judges that the subject is undesirable for this study
Participant flow
After registration, schedule the test with the research subject. The test will be completed in one day.
Research subjects will be required to fast the night before the examination.
The subject will be asked to come directly to the nuclear medicine laboratory at Tohoku University Hospital on the morning of the examination.
Check the eligibility and exclusion criteria (background (medical history) and physical examination).
If there are no problems, you will be asked to change into the examination gown and urinate or defecate.
After ingesting the capsules orally, the subject will consume about 2 ml of commercial olive oil and a glass of milk to stimulate bile secretion for faster absorption.
The CT will be performed at a low dose (tube voltage of 120 kVp and tube current of around 20 mAs).
The examination takes about one hour, and the patient returns home around 5:00 pm. In the morning of the next day, a planar image is taken once and the examination is completed.
After the examination is completed, the patient is observed in the nuclear medicine laboratory, and after confirming that there is no problem in the observation and examination one hour later, the patient is asked to return home.
After the examination, image analysis will be performed to measure the thoracic duct delineation time by 3D thoracic duct scintigraphy and the radiation dose to each organ.
One month later, the final confirmation of the presence or absence of adverse events will be made by telephone.
Adverse events
Adverse events are all unwanted or unintended illnesses or disorders and signs thereof (including abnormal laboratory values) that occur in research subjects and surgeons, etc. for whom the study drug/device diagnosis was performed, regardless of whether or not there is a causal relationship to the study drug/device.
Adverse events will be collected from the time of diagnosis with the study drug/device until the end of the observation period or discontinuation of the individual study subject.
No adverse events were observed.
Outcome measures
1. Measurement of the time it takes for the drug to pass through the stomach, the time it takes for the thoracic duct to be delineated, and the time it takes for the body circulation to be delineated after administration of a radiopharmaceutical encapsulated in a capsule.
2. Measurement of radiation dose to each organ: Radiation dose to each organ using the method proposed by the MIRD (Medical Internal Radiation Dose) Committee, a subordinate organization of the American Society of Nuclear Medicine
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 09 | Day |
Last modified on
| 2021 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031745
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
