A Phase II study of the Perflubutane for predicting TILs in EBC (AppTIL study)

JRCT ID: jRCT1061220081

Registered date:07/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Early Breast Cancer (cStage I-IIIA)
• Date of first enrollment: 16/01/2023
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: Accuracy to predict LPBC in Contrast-enhanced Ultrasonography with Perflubutane (AUC: Area Under the Curve)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Shigematsu Hideo