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COMPLETED

NCT07906158

PET/CT-Based Intratumoral Heterogeneity and Multimodal Imaging for Tumor Diagnosis and Prognosis

Sponsor: Shengjing Hospital

View on ClinicalTrials.gov

Summary

Background \& Rationale: Intratumoral heterogeneity (ITH) is a recognized hallmark and critical driver of therapeutic resistance, rapid disease progression, and poor survival across solid malignancies, notably advanced non-small-cell lung cancer (NSCLC). While tissue biopsies provide histopathologic confirmation, they are invasive and subject to severe spatial sampling bias. Standard whole-tumor radiomics from single-modality CT often masks localized subregional ecological niches. 18F-FDG PET/CT unites glucose metabolic activity with anatomical resolution, offering an ideal non-invasive tool to map whole-tumor spatial and functional heterogeneity in vivo. Methods \& Design: In this multicenter, bidirectional (retrospective and prospective) observational cohort study, 900 advanced NSCLC patients receiving first-line systemic therapies (chemotherapy, anti-PD-1 immunotherapy, and EGFR-TKIs) were enrolled. Baseline 18F-FDG PET/CT scans obtained within 2 weeks prior to therapy were partitioned into distinct biological habitats using entropy-intensity clustering. IBSI-compliant radiomic features were extracted to develop treatment-specific imaging intratumoral heterogeneity (IITH) signatures. Diagnostic accuracy for staging/metastases and prognostic performance for 6-month progression status, progression-free survival (PFS), and overall survival (OS) were comprehensively validated across internal, external multicenter, and independent prospective cohorts, with biological explainability benchmarked against digital histopathology (HoVer-Net nuclear morphometrics) and transcriptomics.

Official title: Application of 18F-FDG PET/CT Multimodal Metabolic-Anatomical Features and Intratumoral Heterogeneity in Tumor Diagnosis, Staging, and First-Line Therapy Prognostic Stratification: A Multicenter Retrospective and Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

OBSERVATIONAL

Enrollment

900

Start Date

2019-02-01

Completion Date

2024-06-30

Last Updated

2026-10-30

Healthy Volunteers

Conditions

Solid Neoplasms Non-Small Cell Lung Cancer

Interventions

OTHER

This is an observational study with no intervention.

Inclusion Criteria: * Aged 18-79 years, male or female; * Confirmed primary solid malignant tumor (non-small cell lung cancer) by histopathological or cytological examination, clinically staged as stage III-IV according to the 8th edition of AJCC/UICC staging system; * Planned to receive or receiving first-line standard systemic therapy (including chemotherapy, anti-PD-1/PD-L1 immune checkpoint inhibitors, or EGFR-TKI targeted therapy); * Standardized baseline 18F-FDG PET/CT examination completed within 2 weeks before the first anti-tumor treatment, with complete whole-body/thoracic metabolic parameters (SUVmax, MTV, etc.) and thin-slice enhanced/non-enhanced CT image sequences; images with satisfactory quality and without severe respiratory motion artifacts; * At least one measurable solid tumor target lesion per RECIST v1.1; * Complete baseline clinicopathological characteristics, baseline laboratory data, and standardized long-term follow-up records (including progression-free survival and overall survival status); * Written informed consent signed by the patient or legal representative (waiver of informed consent for the retrospective part has been approved by the institutional review board). Exclusion Criteria: * Unclear pathological diagnosis, non-primary malignant tumor, or concomitant active second primary malignant tumor at other sites; * Prior surgical resection, radical radiotherapy, or systemic anti-tumor therapy (neoadjuvant therapy, conversion therapy, etc.) targeting the primary lesion before baseline PET/CT examination; * Severe uncontrolled systemic metabolic diseases (e.g., severe diabetes with fasting blood glucose \> 11.1 mmol/L that significantly interferes with 18F-FDG uptake distribution), severe hepatic or renal insufficiency, or severe infection that renders the patient intolerant to examination and follow-up; * Incomplete PET/CT imaging data, contrast medium injection failure, extremely low image signal-to-noise ratio, or severe respiratory motion artifacts/intracorporeal metal implant artifacts which prevent accurate lesion delineation and radiomic analysis; * Severe missing of key clinical follow-up data, loss to follow-up, or inability to accurately determine objective treatment response and survival endpoints.

Locations (1)

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, China