Clinical trial NCT06715826: Target-specific immunoPET Imaging of Breast Cancer
Official title: Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Breast Cancer Metastatic
Keywords: Trop2
HER2
Breast Cancer
ImmunoPET
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biodistribution of [68Ga]Ga-NOTA-T4/[18F]F-RESCA-T4/[68Ga]Ga-DOTA-H2D3 or [18F]F-RESCA-RB14
timeFrame: 1 day from injection of the tracer
measure: Standardized uptake value (SUV)
timeFrame: 1 day from injection of the tracer
measure: Radiation dosimetry of [68Ga]Ga-NOTA-T4/[18F]F-RESCA-T4/[68Ga]Ga-DOTA-H2D3 or [18F]F-RESCA-RB14
timeFrame: 1 day from injection of the tracer
measure: The correlation between Trop2 expression and [68Ga]Ga-NOTA-T4/[18F]F-RESCA-T4 uptake value
timeFrame: 60 days
measure: The correlation between HER2 expression and [68Ga]Ga-DOTA-H2D3/[18F]F-RESCA-RB14 uptake value
timeFrame: 60 days
measure: Diagnostic value of Trop2/HER2-targeted immunPET in patients with breast cancer
timeFrame: 30 days
Secondary outcomes:
measure: 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
timeFrame: 3-6 months
measure: Trop2/HER2-targeted immunPET in changing clinical decision-making for patients with breast cancer
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Weijun Wei, Ph.D. & M.D.
role: STUDY_CHAIR
References: