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

NCT ID: NCT06909604

Last Updated: 2025-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-30

Brief Summary

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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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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 cancer patients treated with neoadjuvant therapy

Group Type EXPERIMENTAL

HER2 expression of PET imaging

Intervention Type 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

Interventions

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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 bladder cancer patients treated with neoadjuvant therapy

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

North Sichuan Medical College

OTHER

Sponsor Role collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University Cancer Hospital & Institute

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoyi Guo, PhD

Role: CONTACT

010-88196495

Yannan Yuan

Role: CONTACT

01088197730

Facility Contacts

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Xiaoyi Guo, PhD

Role: primary

01088196495

Yannan Yuan

Role: backup

01088197730

Other Identifiers

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2019KT114-ZY02

Identifier Type: -

Identifier Source: org_study_id

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