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

NCT06909604 | Recruiting DMC

• 1 other identifier: 2019KT114-ZY02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

breast cancer; PET/CT; Neoadjuvant therapy; HER2 expression

Outcome Measures

Primary Outcomes (1)

• Changes in SUVmax before and after treatment

  The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT

  Before treatment, 9 weeks after treatment, before surgery

Study Arms (1)

HER2 expression of PET imaging

EXPERIMENTAL

Evaluate the diagnostic potential of HER2 imaging using 18F-labelled HER2 affibody , evaluate the predictive and prognostic value of HER2 PET imaging in breast cancer patients treated with neoadjuvant therapy

Radiation: HER2 expression of PET imaging

Interventions

HER2 expression of PET imaging RADIATION

Evaluate the diagnostic potential of HER2 imaging using 18F-labelled HER2 affibody , evaluate the predictive and prognostic value of HER2 PET imaging in bladder cancer patients treated with neoadjuvant therapy

HER2 expression of PET imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• The Affiliated Hospital of Qingdao University: collaborator
• North Sichuan Medical College: collaborator

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, 100142, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xiaoyi Guo, PhD

CONTACT

010-88196495; 15833916752@163.com

Yannan Yuan

CONTACT

01088197730; gcp_yuanyn@bjcancer.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: April 3, 2025
• Study Start: January 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

CN (1)