NCT07906158Completed
PET/CT-Based Intratumoral Heterogeneity and Multimodal Imaging for Tumor Diagnosis and Prognosis
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
Source: ClinicalTrials.gov · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 900 (actual)
- First submitted
- 22 Oct 2026
- Start date
- 1 Feb 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Shengjing Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07906158
What you commit to
- Study type: Observational
- Participants enrolled: 900
- From 1 Feb 2019 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
Lab values
- 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;
Other
- Severe missing of key clinical follow-up data, loss to follow-up, or inability to accurately determine objective treatment response and survival endpoints.
Who the study is looking for
- 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).
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shengjing Hospital affiliated to China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.