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

Peking University Cancer Hospital & Institute

Status: Enrolling

Conditions: Breast Cancer

Treatments: Radiation: HER2 expression of PET imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT06909604

2019KT114-ZY02

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

HER2 expression of PET imaging

Experimental group

Description:

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

Treatment:

Radiation: HER2 expression of PET imaging