Solid NeoplasmsNCT07906158

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

An observational study of Solid Neoplasms and Non-Small Cell Lung Cancer, run by Shengjing Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Solid Neoplasms, Non-Small Cell Lung Cancer
How many people: 900 participants
Where: 1 siteChina
Study dates: 1 Feb 2019to 30 Jun 2024
How long will I take part?: 5 Years
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population is recruited from multiple large tertiary general hospitals and specialized cancer centers including Shengjing Hospital of China Medical University and Liaoning Cancer Hospital. Eligible patients are pathologically confirmed and receive standardized first-line systemic therapy for solid tumors / non-small cell lung cancer. This consecutive lung cancer cohort reflects real-world clinical populations across multiple centers in Northeast China.

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, 110000

Other trials in China

About this study

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

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.

Read the detailed description

This cohort study employs an ambispective design, with both retrospective and prospective phases.

Conditions: Solid Neoplasms, Non-Small Cell Lung Cancer
Being tested: This is an observational study with no intervention.
Keywords: PET/CT, 18F-FDG, Intratumoral Heterogeneity, Radiomics, Habitat Imaging, Non-Small Cell Lung Cancer, Tumor Diagnosis, Prognosis, Progression-Free Survival, Prospective and Retrospective Cohort Study
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

This is an observational study with no intervention.Other
This is an observational study with no intervention.

Study groups in NCT07906158
Study group	Role	What they receive
Retrospective Discovery and Internal Validation Cohort, n=658		Not described Receives: Other: This is an observational study with no intervention.
External Multicenter Validation Cohort, n=129		Not described Receives: Other: This is an observational study with no intervention.
Independent Prospective Validation Cohort, n=113		Not described Receives: Other: This is an observational study with no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

6-Month Progression-Free Survival [PFS] Status
Based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), the risk probability score derived from the baseline 18F-FDG PET/CT multimodal intratumoral heterogeneity model is adopted to predict the binary endpoint of disease progression (PD) or all-cause death within 6 months after patients receive first-line systemic anti-tumor therapy. This binary endpoint evaluates 6 months PFS status in patients.
Measured: Baseline to 6 months post-treatment initiation

Secondary outcomes (3)

Progression-Free Survival
Defined as the time interval from the initiation of first-line systemic anti-tumor therapy to the first documented objective disease progression (per RECIST v1.1) or all-cause death. Kaplan-Meier method will be used to plot survival curves. Log-rank test and multivariate Cox proportional hazards regression model will be applied to evaluate the independent prognostic hazard ratio (HR with 95% confidence interval) and C-index (concordance index) of the PET/CT heterogeneity score.
Measured: Baseline to progression or death, up to 36 months
Overall Survival
Defined as the time interval from the date of histopathologically confirmed tumor diagnosis to all-cause death. The independent predictive performance of the PET/CT multimodal model for long-term all-cause mortality risk will be assessed.
Measured: Up to 60 months
Diagnostic Accuracy for Nodal and Distant Metastases
Metastasis diagnosis description: Using histopathological biopsy or long-term multimodality imaging combined with follow-up as the reference standard, we will evaluate the diagnostic sensitivity, specificity and area under the ROC curve of baseline PET/CT multimodal metabolic and anatomical features for regional mediastinal lymph node metastasis (N staging) and occult distant organ metastasis (M staging).
Measured: within 3 months from baseline to post-treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201930 Jun 2024

First posted30 Oct 2026
Study start1 Feb 2019
Primary completion31 Dec 2023
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid NeoplasmsStudies of the same condition, open and under way.
More trials run by Shengjing HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 900 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT07906158
Sponsor's protocol ID: 2024PS1850K(T1)
Status last verified: Aug 2024
First submitted: 22 Oct 2026
Last updated: 30 Oct 2026
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT07906158
Acronym / sponsor ID: 2024PS1850K(T1)
Conditions: Solid Neoplasms, Non-Small Cell Lung Cancer
Keywords: PET/CT, 18F-FDG, Intratumoral Heterogeneity, Radiomics, Habitat Imaging, Non-Small Cell Lung Cancer, Tumor Diagnosis, Prognosis
Study type: Observational
Recruitment status: Completed
Enrolment: 900 participants (actual)
Lead sponsor: Shengjing HospitalUniversity, hospital or other
Collaborators: First Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Fudan University
Study start: 1 Feb 2019 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 30 Oct 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This cohort study employs an ambispective design, with both retrospective and prospective phases.

Study design

Observational model: Cohort
Time perspective: Other
Target follow-up: 5 Years
Number of arms: 3

Arm	Type	Receives
Retrospective Discovery and Internal Validation Cohort, n=658	–	Other: This is an observational study with no intervention.
External Multicenter Validation Cohort, n=129	–	Other: This is an observational study with no intervention.
Independent Prospective Validation Cohort, n=113	–	Other: This is an observational study with no intervention.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population is recruited from multiple large tertiary general hospitals and specialized cancer centers including Shengjing Hospital of China Medical University and Liaoning Cancer Hospital. Eligible patients are pathologically confirmed and receive standardized first-line systemic therapy for solid tumors / non-small cell lung cancer. This consecutive lung cancer cohort reflects real-world clinical populations across multiple centers in Northeast China.

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
This is an observational study with no intervention.This is an observational study with no intervention.	Other	External Multicenter Validation Cohort, n=129, Independent Prospective Validation Cohort, n=113, Retrospective Discovery and Internal Validation Cohort, n=658

Primary outcome

6-Month Progression-Free Survival [PFS] Status
Time frame: Baseline to 6 months post-treatment initiation
Based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), the risk probability score derived from the baseline 18F-FDG PET/CT multimodal intratumoral heterogeneity model is adopted to predict the binary endpoint of disease progression (PD) or all-cause death within 6 months after patients receive first-line systemic anti-tumor therapy. This binary endpoint evaluates 6 months PFS status in patients.

3 secondary outcomes

Progression-Free Survival
Time frame: Baseline to progression or death, up to 36 months
Overall Survival
Time frame: Up to 60 months
Diagnostic Accuracy for Nodal and Distant Metastases
Time frame: within 3 months from baseline to post-treatment initiation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.

Related trials for Solid Neoplasms

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Solid Neoplasms and Non-Small Cell Lung Cancer, run by Shengjing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-Month Progression-Free Survival [PFS] Status (time frame: Baseline to 6 months post-treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07906158.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.