Target-specific immunoPET Imaging of Breast Cancer

Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Neoplasms; Breast Cancer Metastatic
• Intervention / Treatment: Drug: [18F]F-RESCA-RB14; Drug: [18F]F-RESCA-RT4

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Weijun Wei, Ph.D. & M.D.; Phone Number: 15000083153; Email: wwei@shsmu.edu.cn
• Study Contact Backup: Name: Wenzhi Jia, Ph.D. & M.D.; Phone Number: 18317076979; Email: jwzdata@126.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200127
      • Recruiting
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Contact: Weijun Wei, Ph.D. & M.D.; Phone Number: 15000083153; Email: wwei@shsmu.edu.cn
      • Contact: Wenzhi Jia, Ph.D. & M.D.; Phone Number: 18317076979; Email: jwzdata@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trop2/HER2-targeted immunoPET imaging; Enrolled patients will undergo a Trop2/HER2-targeted immunoPET/CT scanning.	Drug: [18F]F-RESCA-RB14; Enrolled patients will receive 0.05-0.1mCi/kg of [18F]F-RESCA-RB14. ImmunoPET/CT imaging will be acquired 1 hour after [18F]F-RESCA-RB14 injection.; Other Names: [18F]F-RB14; Drug: [18F]F-RESCA-RT4; Enrolled patients will receive 0.05-0.1mCi/kg of [18F]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1 hour after [18F]F-RESCA-RT4 injection.; Other Names: [18F]F-RT4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biodistribution of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14	Measurement of the overall biodistribution of above probes in normal tissues and organs.	1 day from injection of the tracer
Standardized uptake value (SUV)	Standardized uptake value (SUV) of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 in the included subjects' primary and/or metastatic lesions.	1 day from injection of the tracer
Radiation dosimetry of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14	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.	1 day from injection of the tracer
The correlation between Trop2 expression and [18F]F-RESCA-RT4 uptake value	The Standardized uptake value (SUV) of [18F]F-RESCA-RT4 will be calculated, and the correlation between pathological results and tumor uptake of[18F]F-RESCA-T4 will be analyzed.	60 days
The correlation between HER2 expression and [18F]F-RESCA-RB14 uptake value	Standardized uptake value (SUV) of [18F]F-RESCA-RB14 will be calculated, and the correlation between pathological results and tumor uptake of [18F]F-RESCA-RB14 will be analyzed.	60 days
Diagnostic value of Trop2/HER2-targeted immunPET in patients with breast cancer	We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of [18F]F-RESCA-RT4/[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[18F]F-RESCA-RT4/[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 [18F]F-RESCA-RT4/[18F]F-RESCA-RB14 PET/CT for patients with breast cancer.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The predictive value of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 in the course of targeted therapies	Baseline and follow-up [18F]F-RESCA-RT4/ [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.	3-6 months
Trop2/HER2-targeted immunPET in changing clinical decision-making for patients with breast cancer	After analyzing the imaging parameters and diagnostic/predictive value of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14 PET/CT, we will also investigate how clinical use of [18F]F-RESCA-RT4/[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.	3-6 months

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: Weijun Wei, Ph.D. & M.D., Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; HER2; Trop2; ImmunoPET
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: KY2024-095-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No