A Phase II study of the efficacy and safety of Perflubutane for predicting highly Tumor Infiltrating Lymphocytes in early breast cancer (AppTIL study)

A Phase II study of the efficacy and safety of Perflubutane for predicting highly Tumor Infiltrating Lymphocytes in early breast cancer (AppTIL study) - A Phase II study of the Perflubutane for predicting TILs in EBC (AppTIL study)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000050067

Enrollment

100

Registered

2023-01-18

Start date

2023-01-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Breast Cancer (cStage I-IIIA)

Interventions

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 0.0

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactYuri Kimura

Hiroshima University Hospital Department of Breast Surgery

yuri.k@ymail.ne.jp082-257-5869

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026