UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050067 |
|---|---|
| Receipt number | R000057037 |
| Scientific Title | A Phase II study of the efficacy and safety of Perflubutane for predicting highly Tumor Infiltrating Lymphocytes in early breast cancer (AppTIL study) |
| Date of disclosure of the study information | 2023/01/18 |
| Last modified on | 2023/07/20 14:16:19 |
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Basic information
Public title
A Phase II study of the efficacy and safety of Perflubutane for predicting highly Tumor Infiltrating Lymphocytes in early breast cancer (AppTIL study)
Acronym
A Phase II study of the Perflubutane for predicting TILs in EBC (AppTIL study)
Scientific Title
A Phase II study of the efficacy and safety of Perflubutane for predicting highly Tumor Infiltrating Lymphocytes in early breast cancer (AppTIL study)
Scientific Title:Acronym
A Phase II study of the Perflubutane for predicting TILs in EBC (AppTIL study)
Region
| Japan |
Condition
Condition
Early Breast Cancer (cStage I-IIIA)
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of perflubutane administration to patients with early-stage breast cancer by using ultrasonography as a diagnostic predictor of TIL-rich breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Accuracy to predict LPBC in Contrast-enhanced Ultrasonography with Perflubutane (AUC: Area Under the Curve)
Key secondary outcomes
1. Sensitivity, specificity, positive predictive value, positive predictive value, and negative predictive value for predicting LPBC in contrast-enhanced ultrasonography using Perflubutane
2. Sensitivity, specificity, positive predictive value, positive predictive value, negative predictive value, and AUC for predicting LPBC in TILs-US score + Vascularity
3. Sensitivity, specificity, positive predictive value, positive predictive value, negative predictive value, and AUC of LPBC prediction in TILs-US score
4. Concordance rate of TILs assessment between core needle biopsy and surgical specimen
5. Safety of contrast-enhanced ultrasonography using perflubutane
6. Characteristic findings of LPBC in contrast-enhanced ultrasonography using Perflubutane
7. Adverse events
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
Product name: Sonazoid for injection 16microliter
Generic name: Perflubutane
16 microliter (1 vial) of Perflubutane microbubble is suspended in 2 mL of the solution for injection provided, and 0.015 mL/kg of the suspended solution is usually administered intravenously once per adult.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are at least 18 years of age at the time of consent
2. Patients with histologically confirmed invasive breast cancer
3. Patients diagnosed with clinical stage I-IIIA
4. Patients scheduled for radical surgery
5. Patients with mass lesions evaluable by ultrasonography
6. Patients with ECOG PS 0-2
7. Patients who provide written consent for participation in this study
Key exclusion criteria
1. Patients undergoing preoperative treatment for breast cancer
2. Patients with a history of breast cancer on the affected side
3. Patients with a history of hypersensitivity to perflubutane
4. Patients with allergy to eggs or egg products
5. Patients with arteriovenous shunts in the heart or lungs
6. Patients with serious cardiac or pulmonary disease
7. Patients deemed inappropriate by the principal investigator or subinvestigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Shigematsu |
Organization
Hiroshima University Hospital
Division name
Department of Breast Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima
TEL
082-257-5869
shigematu1330@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Kimura |
Organization
Hiroshima University Hospital
Division name
Department of Breast Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima
TEL
082-257-5869
Homepage URL
yuri.k@ymail.ne.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Yuri Kimura
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Certified Review Board
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, , Hiroshima, Hiroshima, Hiroshima
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
CRB6180006
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057037
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