Clinical trial NCT06851663: Trop2-targeted immunoPET Imaging of Solid Tumors
Official title: Trop2-targeted immunoPET Imaging of Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor
Solid Carcinoma
Uroepithelial Carcinoma
Bladder Cancer
Prostate Cancer
Lung Cancer
Nasopharyngeal Cancer
Liver Cancer
Cholangiocarcinoma
Ovarian Cancer
Cervical Cancer
Endometrial Cancer
Thyroid Cancer
Head and Neck Cancer
Keywords: Trophoblast cell surface antigen 2 (Trop2)
ImmunoPET
Solid Tumor
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 400
Sex: ALL
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: This study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.

Detailed description: Histologically confirmed solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer), or patients with suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) indicated by conventional diagnostic imaging will be included. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.

Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors 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 assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.

Eligibility criteria: Inclusion Criteria:

* Aged 18-75 year-old and of either sex
* Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) or suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) by diagnostic imaging;
* Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.

Exclusion Criteria:

* Pregnancy；
* Severe hepatic and renal insufficiency;
* Allergic to single-domain antibody radiopharmaceuticals.

Primary outcomes:
measure: Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.
timeFrame: 1 day from injection of the tracers
measure: SUV of tumors
timeFrame: 1 day from injection of the tracers
measure: Radiation dosimetry of tissues/organs
timeFrame: 1 day from injection of the tracers
measure: Radiation dosimetry of tumors
timeFrame: 1 day from injection of the tracers
measure: Radiation dosimetry of whole-body
timeFrame: 1 day from injection of the tracers
measure: Diagnostic sensitivity
timeFrame: 30 days
measure: Diagnostic specificity
timeFrame: 30 days
measure: Accuracy
timeFrame: 30 days
measure: Positive Predictive Value (PPV)
timeFrame: 30 days
measure: Negative Predictive Value (NPV)
timeFrame: 30 days
Secondary outcomes:
measure: Trop2 immunoPET/CT in altering initial staging for patients with solid tumors
timeFrame: 3-6 months
measure: Trop2 immunoPET/CT for postoperative surveillance for patients with solid tumors
timeFrame: 3-6 months
measure: Trop2 immunoPET/CT for restaging for patients with solid tumors
timeFrame: 3-6 months
measure: Trop2 immunoPET/CT in evaluating treatment responses
timeFrame: 1-2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Jianjun Liu, Ph.D. & M.D.
role: STUDY_CHAIR
affiliation: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Weijun Wei, Ph.D. & M.D.
role: PRINCIPAL_INVESTIGATOR
References: