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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06909604
Acronym
FHERAD
Enrollment
50
Registered
2025-04-03
Start date
2025-01-01
Completion date
2026-12-30
Last updated
2026-05-13

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

Conditions

Breast Cancer

Keywords

breast cancer, PET/CT, HER2 expression, ADC therapy

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 ADC therapy

Interventions

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

Sponsors

Peking University Cancer Hospital & Institute
Lead SponsorOTHER
The Affiliated Hospital of Qingdao University
CollaboratorOTHER
North Sichuan Medical College
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in SUVmax before and after treatmentBefore treatment, 9 weeks after treatment, before surgeryThe uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT

Countries

China

Contacts

CONTACTXiaoyi Guo, PhD
15833916752@163.com010-88196495
CONTACTYannan Yuan
gcp_yuanyn@bjcancer.org01088197730

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026