Contrast-Enhanced Ultrasound Assessment Model for Pathological Complete Response after Neoadjuvant Therapy in Rectal Cancer: A Prospective Study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500112085

Enrollment

Unknown

Registered

2025-11-10

Start date

2025-11-20

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Rectal Cancer

Interventions

Gold Standard:Surgical pathological diagnosis

Index test:Ultrasound, Sonazoid contrast-enhanced ultrasound, super-resolution ultrasound (using contrast-enhanced images for post-processing and data analysis), CT and/or MRI(if available)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years; 2. Pathologically confirmed rectal carcinoma, having completed neoadjuvant therapy, with radical surgical treatment planned within 6–12 weeks post-neoadjuvant therapy; 3. Capable of independent decision-making and able to sign the informed consent form; 4. Agrees to undergo contrast-enhanced ultrasound examination following completion of neoadjuvant therapy and prior to surgery.

Exclusion criteria

Exclusion criteria: 1.Women who are pregnant or breastfeeding; 2.Patients with contraindications to either Sonazoid or SonoVue contrast-enhanced ultrasound; 3. Patients who have undergone previous local therapy such as thermal ablation for the target lesion; 4. Patients who are clinically unstable, have end-stage disease, or have an unpredictable clinical course.

Design outcomes

Primary

Measure	Time frame
Sensitivity;Specificity;Area under the curve (AUC);	—

Countries

China

Contacts

Public ContactZhou Jianhua

Sun Yat-sen University Cancer Center

zhoujh@sysucc.org.cn+86 137 1175 7623

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026