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

May 8, 2026 updated by: Peking University Cancer Hospital & Institute

Al18F-HER2-BCH PET/CT to Predict Response 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital & Institute
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged ≥18 years old; ECOG 0 or 1;
  2. Patients with HER2 positive or low 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HER2 expression of PET imaging
Evaluate the predict 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 ADC therapy
Radiation: HER2 expression of PET imaging
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before treatment, 9 weeks after treatment, before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Collaborators

The Affiliated Hospital of Qingdao University
North Sichuan Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019KT114-ZY02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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