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NCT Number: NCT06715826

Target-specific immunoPET Imaging of 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.

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Key information

Conditions

Breast Cancer Breast Cancer Metastatic Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

[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.

Other names: [18F]F-RT4

[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.

Other names: [18F]F-RB14

Primary outcomes

  1. Biodistribution of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14

    Time frame: 1 day from injection of the tracer

    Measurement of the overall biodistribution of above probes in normal tissues and organs.

  2. Standardized uptake value (SUV)

    Time frame: 1 day from injection of the tracer

    Standardized uptake value (SUV) of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 in the included subjects' primary and/or metastatic lesions.

  3. Radiation dosimetry of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14

    Time frame: 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.

  4. The correlation between Trop2 expression and [18F]F-RESCA-RT4 uptake value

    Time frame: 60 days

    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.

  5. The correlation between HER2 expression and [18F]F-RESCA-RB14 uptake value

    Time frame: 60 days

    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.

  6. Diagnostic value of Trop2/HER2-targeted immunPET in patients with breast cancer

    Time frame: 30 days

    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.

Secondary outcomes

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

    Time frame: 3-6 months

    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.

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

    Time frame: 3-6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

15000083153

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

CONTACT

[email protected]

18317076979

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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