UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006003 |
|---|---|
| Receipt number | R000007104 |
| Scientific Title | Diagnostic Performance of PET/CT and Bone Scintigraphy in Breast Cance Patients with Suspected Bone Metastasis |
| Date of disclosure of the study information | 2011/07/20 |
| Last modified on | 2015/07/19 09:23:26 |
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Basic information
Public title
Diagnostic Performance of PET/CT and Bone Scintigraphy in Breast Cance Patients with Suspected Bone Metastasis
Acronym
Diagnostic Performance of PET/CT and Bone Scintigraphy in Breast Cance Patients with Suspected Bone Metastasis
Scientific Title
Diagnostic Performance of PET/CT and Bone Scintigraphy in Breast Cance Patients with Suspected Bone Metastasis
Scientific Title:Acronym
Diagnostic Performance of PET/CT and Bone Scintigraphy in Breast Cance Patients with Suspected Bone Metastasis
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare sensitivity and specificity between PET/CT and Bone scintigraphy to detect bone metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sensitivity and specificity
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
| Device,equipment |
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
Age 20-75
Patient had breast cancer
ECOG PS0-1
Localized symptoms
Elevated alkaline phosphatase
Elevated tumor marker
Patients with bone metastases suspected by bone scintigraphy
Key exclusion criteria
Prior diagnosed bone metastases from breast cancer
ECOG PS0-1
Pre-existing pulmonary and/or cardiac disease
Pre-existing ascites and pleural effusion.
Pre-existing infection disease
Patient have drug allergy
Pre-existing mental disorder
Prior autologous bone marrow transplantation
Pre-existing brain metastasis
History of any other cancer (except no-invasive cancer)
Pregnant or sexually active women not using reliable contraception
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Tokuda |
Organization
Tokai University school of medicine
Division name
Department Breast and Endocrine Surgery
Zip code
Address
143 Shimokasuya Isehara Kanagawa
TEL
0463-93-1121
niikura@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Niikura |
Organization
Tokai University school of medicine
Division name
Department Breast and Endocrine Surgery
Zip code
Address
143 Shimokasuya Isehara
TEL
1463931121
Homepage URL
niikura@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University school of medicine Department of Breast Endocrine Surgery
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26037335
Number of participants that the trial has enrolled
Results
Our results indicated that PET/CT was superior to BS for the diagnosis of bone metastases. On the basis of the results of previous studies as well as ours, PET/CT could replace BS as the initial modality to detect bone metastases in patients suspected for the condition.
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
Main results already published
Date of protocol fixation
| 2011 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 19 | Day |
Last modified on
| 2015 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007104
