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

Phase 2

Recruiting

• Conditions: Early Breast Cancer (cStage I-IIIA); Breast Cancer, TIL, Tumor Infiltrating Lymphocyte, LPBC, Contrast-enhanced ultrasonography, US, Perflubutane, Sonazoid

• Registration Number: JPRN-jRCT1061220081
• Lead Sponsor: Shigematsu Hideo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy to predict LPBC in Contrast-enhanced Ultrasonography with Perflubutane (AUC: Area Under the Curve)

Secondary Outcome Measures

Name	Time	Method
1. Sensitivity, specificity, positive predictive value, positive predictive value, and negative predictive value for predicting LPBC in contrast-enhanced ultrasonography using Perflubutane<br>2. Sensitivity, specificity, positive predictive value, positive predictive value, negative predictive value, and AUC for predicting LPBC in TILs-US score + Vascularity<br>3. Sensitivity, specificity, positive predictive value, positive predictive value, negative predictive value, and AUC of LPBC prediction in TILs-US score<br>4. Concordance rate of TILs assessment between core needle biopsy and surgical specimen<br>5. Safety of contrast-enhanced ultrasonography using perflubutane<br>6. Characteristic findings of LPBC in contrast-enhanced ultrasonography using Perflubutane<br>7. Adverse events