Target-specific immunoPET Imaging of Breast Cancer

NCT06715826 | Recruiting Phase 1 DMC

• 1 other identifier: KY2024-095-A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms; Breast Cancer Metastatic

Keywords

Trop2; HER2; Breast Cancer; ImmunoPET

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• The predictive value of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 in the course of targeted therapies

  3-6 months

• Trop2/HER2-targeted immunPET in changing clinical decision-making for patients with breast cancer

  3-6 months

Study Arms (1)

Trop2/HER2-targeted immunoPET imaging

EXPERIMENTAL

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

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

Interventions

[18F]F-RESCA-RT4 DRUG

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.

Also known as: [18F]F-RT4

Trop2/HER2-targeted immunoPET imaging

[18F]F-RESCA-RB14 DRUG

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.

Also known as: [18F]F-RB14

Trop2/HER2-targeted immunoPET imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Weijun Wei, Ph.D. & M.D.

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

Central Study Contacts

Weijun Wei, Ph.D. & M.D.

CONTACT

15000083153; wwei@shsmu.edu.cn

Wenzhi Jia, Ph.D. & M.D.

CONTACT

18317076979; jwzdata@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: September 21, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CN (1)