UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017446 |
|---|---|
| Receipt number | R000020224 |
| Scientific Title | Utility study of PET imaging with 64Cu-DOTA labeled antibody probes against HER2 and EGFR |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2017/12/04 21:24:44 |
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Basic information
Public title
Utility study of PET imaging with 64Cu-DOTA labeled antibody probes against HER2 and EGFR
Acronym
Cu-DOTA molecular imaging
Scientific Title
Utility study of PET imaging with 64Cu-DOTA labeled antibody probes against HER2 and EGFR
Scientific Title:Acronym
Cu-DOTA molecular imaging
Region
| Japan |
Condition
Condition
Breast cancer, Gastric cancer, Colorectal cancer, Glioma
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery | Breast surgery |
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine efficacy and safety of PET imaging with 64Cu-DOTA labeled antibody probes against HER2 and EGFR.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visualization of PET imaging with 64Cu-DOTA labeled antibody probes against HER2 and EGFR.
Comparison between PET imaging and expression of HER2 and EGFR.
Key secondary outcomes
Safety of HER2- and EGFR-PET imaging.
Comparison between standardized uptake value on PET imaging and expression of HER2 and EGFR.
Comparison between intratumoral uptake of 64Cu-DOTA labeled antibody probes and expression of HER2 and EGFR (in specific cases).
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
64Cu-DOTA labeled antibody probes against HER2 and EGFR
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
| 25 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with invasive breast cancer, gastric cancer, colorectal cancer or glioma.
2. Age: >20 years, <75 years
3. ECOG performance status: 0-2
4. Capable of imaging by PET
5. Good main organ function
6. Signed informed consent
Key exclusion criteria
1. Severe drug hypersensitivity
2. Ischemic heart disease, cardiomyopathy, congestive heart failure and uncontrolled arrhythmia
3. Active infectious disease, interstitial pneumonia and pulmonary fibrosis
4. Organ insufficiency (bone marrow, liver and kidney)
5. Active synchronous double cancer
6. Pregnancy and lactating (including possibility and intention)
7. Decision of the physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Tamura |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
ketamura@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Tamura |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
ketamura@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 30 | Day |
Other
Other related information
https://academic.oup.com/annonc/article/28/8/2028/3827471
https://link.springer.com/article/10.1007%2Fs00259-017-3781-6
Management information
Registered date
| 2015 | Year | 05 | Month | 07 | Day |
Last modified on
| 2017 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020224
