JPRN-jRCT1061220081RecruitingPhase 2
A Phase II study of the efficacy and safety of Perflubutane for predicting highly Tumor Infiltrating Lymphocytes in early breast cancer (AppTIL study)
Shigematsu Hideo0 sites100 target enrollmentStarted: January 7, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
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
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
Investigators
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