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NCT Number: NCT06909604

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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 breast patients treated with ADC therapy

Primary outcomes

  1. Changes in SUVmax before and after treatment

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoyi Guo, PhD

CONTACT

[email protected]

010-88196495

Yannan Yuan

CONTACT

[email protected]

01088197730

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Collaborators

  • North Sichuan Medical College
  • The Affiliated Hospital of Qingdao University

Registry information

Official study title

Al18F-HER2-BCH PET/CT to Predict Response in Breast Patients Treated With ADC Therapy

Acronym: FHERAD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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