Al18F-HER2-BCH PET in Breast Patients Treated With Neoadjuvant Therapy

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06909604
• Lead Sponsor: Peking University Cancer Hospital & Institute

Brief Summary

To use the molecular PET radionuclide (F-18) labelled HER2 Affibody to evaluate the predictive and prognostic value in breast patients treated with neoadjuvant therapy

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-24
• Study Start: 2025-01-01
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Aged ≥18 years old; ECOG 0 or 1;
2. Patients with newly diagnosis HER2 positive or suspicious positive tumors;
3. Receives neoadjuvant therapy
4. Has adequate cardiac, bone marrow, renal, hepatic and blood clotting functions;
5. Life expectancy > 3 months -

Exclusion Criteria

1. Significant hepatic or renal dysfunction;
2. Is pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refused to join the clinical research;
5. Suffering from claustrophobia or other mental disorders;
6. Any other situation that researchers considered it unsuitable to participate in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in SUVmax before and after treatment	Before treatment, 9 weeks after treatment, before surgery	The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT

Trial Locations

Locations (1)

Peking University Cancer Hospital & Institute; 🇨🇳 Beijing, China