Target-specific immunoPET Imaging of Breast Cancer

Not Applicable

Recruiting

• Conditions: Breast Cancer Metastatic; Breast Cancer; Breast Neoplasms
• Interventions: Drug: [68Ga]Ga-NOTA-T4; Drug: [18F]F-RESCA-T4; Drug: [68Ga]Ga-DOTA-H2D3; Drug: [18F]F-RESCA-RB14

• Registration Number: NCT06715826
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

Detailed Description

Enrolled patients will undergo whole-body \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4(Trop2-targeted imaging probes ) or \[68Ga\]Ga-DOTA-H2D3/\[18F\]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.

Study Timeline

• Study Start: 2024-09-21
• Status Verified: 2024-11
• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trop2/HER2-targeted immunoPET imaging	[68Ga]Ga-DOTA-H2D3	Enrolled patients will undergo a Trop2/HER2-targeted immunoPET/CT scanning.
Trop2/HER2-targeted immunoPET imaging	[18F]F-RESCA-RB14	Enrolled patients will undergo a Trop2/HER2-targeted immunoPET/CT scanning.
Trop2/HER2-targeted immunoPET imaging	[68Ga]Ga-NOTA-T4	Enrolled patients will undergo a Trop2/HER2-targeted immunoPET/CT scanning.
Trop2/HER2-targeted immunoPET imaging	[18F]F-RESCA-T4	Enrolled patients will undergo a Trop2/HER2-targeted immunoPET/CT scanning.

Primary Outcome Measures

Name	Time	Method
Biodistribution of [68Ga]Ga-NOTA-T4/[18F]F-RESCA-T4/[68Ga]Ga-DOTA-H2D3 or [18F]F-RESCA-RB14	1 day from injection of the tracer	Measurement of the overall biodistribution of above probes in normal tissues and organs.
Standardized uptake value (SUV)	1 day from injection of the tracer	Standardized uptake value (SUV) of \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4/\[68Ga\]Ga-DOTA-H2D3 or \[18F\]F-RESCA-RB14 in the included subjects' primary and/or metastatic lesions.
Radiation dosimetry of [68Ga]Ga-NOTA-T4/[18F]F-RESCA-T4/[68Ga]Ga-DOTA-H2D3 or [18F]F-RESCA-RB14	1 day from injection of the tracer	Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs, tumor(s), and whole body (Sv/MBq). Dynamic imaging within one hour will be acquired for the purpose.
The correlation between Trop2 expression and [68Ga]Ga-NOTA-T4/[18F]F-RESCA-T4 uptake value	60 days	The Standardized uptake value (SUV) of \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4 will be calculated, and the correlation between pathological results and tumor uptake of \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4 will be analyzed.
The correlation between HER2 expression and [68Ga]Ga-DOTA-H2D3/[18F]F-RESCA-RB14 uptake value	60 days	Standardized uptake value (SUV) of \[68Ga\]Ga-DOTA-H2D3/\[18F\]F-RESCA-RB14 will be calculated, and the correlation between pathological results and tumor uptake of \[68Ga\]Ga-DOTA-H2D3/\[18F\]F-RESCA-RB14 will be analyzed.
Diagnostic value of Trop2/HER2-targeted immunPET in patients with breast cancer	30 days	We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4/\[68Ga\]Ga-DOTA-H2D3 or \[18F\]F-RESCA-RB14 PET/CT in patients with breast cancer. We will also compare the diagnostic value of above probes with that of traditional imaging tracers (e.g., 18F-FDG) and imaging modalities (e.g., MRI). All the above goals will be achieved by analyzing the static/dynamic \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4/\[68Ga\]Ga-DOTA-H2D3 or \[18F\]F-RESCA-RB14 PET/CT imaging data. Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics, and, more importantly, the clinical value of \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4/\[68Ga\]Ga-DOTA-H2D3 or \[18F\]F-RESCA-RB14 PET/CT for patients with breast cancer.

Secondary Outcome Measures

Name	Time	Method
The predictive value of [68Ga]Ga-NOTA-T4/[18F]F-RESCA-T4/[68Ga]Ga-DOTA-H2D3 or [18F]F-RESCA-RB14 in the course of targeted therapies	3-6 months	Baseline and follow-up \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4/\[68Ga\]Ga-DOTA-H2D3 or \[18F\]F-RESCA-RB14 immunoPET imaging in targeted therapy will be investigated in this setting to determine the value of Trop2/HER2 immunoPET imaging in predicting or evaluating treatment responses.
Trop2/HER2-targeted immunPET in changing clinical decision-making for patients with breast cancer	3-6 months	After analyzing the imaging parameters and diagnostic/predictive value of \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4/\[68Ga\]Ga-DOTA-H2D3 or \[18F\]F-RESCA-RB14 PET/CT, we will also investigate how clinical use of \[68Ga\]Ga-NOTA-T4/\[18F\]F-RESCA-T4/\[68Ga\]Ga-DOTA-H2D3 or \[18F\]F-RESCA-RB14 PET/CT changes clinical decision-making for patients with breast cancer. Joint efforts from nuclear medicine physicians, breast surgeons, oncologists, and pathologists will draw solid conclusions from the imaging and clinical information.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China