Target-specific immunoPET Imaging of Breast Cancer

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Breast Cancer; Breast Cancer Metastatic; Breast Neoplasms

Treatments: Drug: [18F]F-RESCA-RB14; Drug: [18F]F-RESCA-RT4

Study type: Interventional

Funder types: Other

Identifiers

NCT06715826

KY2024-095-A

Details and patient eligibility

About

The aim of this study is to establish and optimize the Trop2/HER2-targeted PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in breast cancer will be evaluated.

Full description

Enrolled patients will undergo whole-body[18F]F-RESCA-RT4(Trop2-targeted imaging probes ) or [18F]F-RESCA-RB14(HER2-targeted imaging probes) PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively.

Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18-75 years old and of female gender；
2. Histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging;
3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Exclusion criteria

1. Pregnancy；
2. Severe hepatic and renal insufficiency;
3. History of serious surgery in the last month;
4. Allergic to antibody or single-domain antibody radiopharmaceuticals.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Trop2/HER2-targeted immunoPET imaging

Experimental group

Description:

Enrolled patients will undergo a Trop2/HER2-targeted immunoPET/CT scanning.

Treatment:

Drug: [18F]F-RESCA-RT4

Drug: [18F]F-RESCA-RB14