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Recruiting NCT06715826

Target-specific immunoPET Imaging of Breast Cancer

Phase I / Phase II Interventional Breast Cancer Breast Neoplasms Breast Cancer Metastatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [18F]F-RESCA-RT4, [18F]F-RESCA-RB14.
Who it may be relevant to
Registry conditions: Breast Cancer, Breast Neoplasms, Breast Cancer Metastatic. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer

Overview

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\[18F\]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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Biodistribution of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 [Time frame: 1 day from injection of the tracer]
  • Standardized uptake value (SUV) [Time frame: 1 day from injection of the tracer]
  • Radiation dosimetry of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14 [Time frame: 1 day from injection of the tracer]
  • The correlation between Trop2 expression and [18F]F-RESCA-RT4 uptake value [Time frame: 60 days]
  • The correlation between HER2 expression and [18F]F-RESCA-RB14 uptake value [Time frame: 60 days]
  • Diagnostic value of Trop2/HER2-targeted immunPET in patients with breast cancer [Time frame: 30 days]
Secondary outcome measures (2)
  • The predictive value of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 in the course of targeted therapies [Time frame: 3-6 months]
  • Trop2/HER2-targeted immunPET in changing clinical decision-making for patients with breast cancer [Time frame: 3-6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai

Identifiers

NCT: NCT06715826 · KY2024-095-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗