NSCLCNCT04553601
Molecular Imaging Visualization of Tumor Heterogeneity in Non-small Cell Lung Cancer
A study testing 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants in people with NSCLC and PET/CT, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
To assess the potential usefulness of radiogenomics for tumor driving genes heterogeneity in non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 1 Oct 2022
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- (i) patients with non-malignant lesions;
- (ii) patients with pregnancy;
- (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of xiamen university
Xiamen, Fujian, 0086-361000
Long Sun, doctor, 86 0592-2137077, 13178352662@163.com
About this study
To assess the potential usefulness of radiogenomics for tumor driving genes heterogeneity in non-small cell lung cancer.
Read the detailed description
Patients with advanced NSCLC underwent 18F-FDG PET/CT and PET/CT-guided synchronous targeted biopsy of primary and distant metastatic tumors. The LIFEx package was used to extract PET and CT radiomic features from primary and metastatic lesions. The radiomic ROI sites of primary and distant metastatic tumors were point-to-point corresponding to the PET/ CT-guided targeted biopsy sites. Whole exon sequencing of primary and distant metastatic tumor samples obtained by PET/CT-guided targeted biopsy was used to get genomic data of primary and distant metastatic tumor. Predictive radiogenomics models were established and validation.
- Being tested
- 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants
- Keywords
- NSCLC, PET/CT, radiogenomics
- 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.
18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participantsDiagnostic test
Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time
| Study group | Role | What they receive |
|---|---|---|
| 8F-FDG PET/CT and PET/CT-guide targeted biopsy | Experimental | Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time. Receives: Diagnostic Test: 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiomic feature selection and model establishment
In this study, the investigators first selected the features with significant differences between genes mutant and wild type in the training set using the Mann-Whitney U test, obtaining a total of 53 features with p value < 0.05. Then, the least absolute shrinkage and selection operator (LASSO) algorithm was used to select the optimal predictive features among the 53 selected in the training set. The LASSO algorithm adds a L1 regularization term to a least square algorithm to avoid overfitting. A prediction model was established by logistic regression, and the radiomics signature score (rad-score) for each participant was calculated based on the selected discriminating radiomic features. The model performance was tested in the validation set. The receiver operating characteristic (ROC) curve and the area under the curve (AUC) were used to evaluate the model performance in the training and validation sets.
Measured: 3 years
Secondary outcomes (3)
Genes mutation detection
Genes mutation detection was performed on histological specimens obtained by surgical resection or puncture. Genes mutation detection was conducted by the examination of the whole-exome sequencing. The whole-exome sequencing is performed by the Novogene company (www.novogene.com). If any genes mutation in the whole-exome sequencing was detected, the tumor was considered genes mutant. Otherwise, the tumor was classified as no mutant of genes type.
Measured: 30 days
Image acquisition
The imaging acquisition protocol was established following the Image Biomarker Standardisation Initiative (IBSI) reporting guidelines. All the details of the procedures are provided in the electronic supplementary material. 18F-FDG PET/CT (Discovery MI, GE Healthcare, Milwaukee, WI, USA) examination was performed within 1 month before treatment. Briefly, 18F-FDG PET/CT images were acquired 60 ± 5 min after 18F-FDG injection in accordance with the European Association of Nuclear Medicine (EANM) guidelines, version 1.0 (version 2.0 from February 2015). A 3D LOR reconstruction algorithm was used to reconstruct the PET images. The attenuation correction of PET images was carried out with CT data, and the corrected PET images were fused with CT images.
Measured: 30 days
Radiomic feature extraction
The LIFEx package (version 4.00, http://www.lifexsoft.org) was used to extract the texture features of PET/CT images of lesions in the same VOI. The PET/CT image of the patient in the DICOM format was imported into the software. Two experienced PET/CT diagnostic physicians semi-automatically delineated the region of interest of the target lesion using a threshold of 40% of the maximum standardized uptake value (SUVmax). Then, the software program automatically calculates and extracts 47 PET radiomic features and 45 CT radiomic features.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Oct 2019
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with advanced NSCLC underwent 18F-FDG PET/CT and PET/CT-guided synchronous targeted biopsy of primary and distant metastatic tumors.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Long Sun, PhD, Principal investigator, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553601
- Sponsor's protocol ID
- KYH2019-039
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging Visualization of Tumor Heterogeneity in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04553601
- Acronym / sponsor ID
- KYH2019-039
- Keywords
- NSCLC, PET/CT, radiogenomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 17 Sep 2020 (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.
To assess the potential usefulness of radiogenomics for tumor driving genes heterogeneity in non-small cell lung cancer.
Detailed description
Patients with advanced NSCLC underwent 18F-FDG PET/CT and PET/CT-guided synchronous targeted biopsy of primary and distant metastatic tumors. The LIFEx package was used to extract PET and CT radiomic features from primary and metastatic lesions. The radiomic ROI sites of primary and distant metastatic tumors were point-to-point corresponding to the PET/ CT-guided targeted biopsy sites. Whole exon sequencing of primary and distant metastatic tumor samples obtained by PET/CT-guided targeted biopsy was used to get genomic data of primary and distant metastatic tumor. Predictive radiogenomics models were established and validation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with advanced NSCLC underwent 18F-FDG PET/CT and PET/CT-guided synchronous targeted biopsy of primary and distant metastatic tumors.
| Arm | Type | Receives |
|---|---|---|
| 8F-FDG PET/CT and PET/CT-guide targeted biopsy | Experimental | Diagnostic Test: 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participantsEach subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- (i) patients with non-malignant lesions;
- (ii) patients with pregnancy;
- (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
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 |
|---|---|---|
| 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participantsEach subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time | Diagnostic test | 8F-FDG PET/CT and PET/CT-guide targeted biopsy |
Primary outcome
Radiomic feature selection and model establishment
Time frame: 3 years
In this study, the investigators first selected the features with significant differences between genes mutant and wild type in the training set using the Mann-Whitney U test, obtaining a total of 53 features with p value < 0.05. Then, the least absolute shrinkage and selection operator (LASSO) algorithm was used to select the optimal predictive features among the 53 selected in the training set. The LASSO algorithm adds a L1 regularization term to a least square algorithm to avoid overfitting. A prediction model was established by logistic regression, and the radiomics signature score (rad-score) for each participant was calculated based on the selected discriminating radiomic features. The model performance was tested in the validation set. The receiver operating characteristic (ROC) curve and the area under the curve (AUC) were used to evaluate the model performance in the training and validation sets.
3 secondary outcomes
Genes mutation detection
Time frame: 30 days
Image acquisition
Time frame: 30 days
Radiomic feature extraction
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Long Sun, PhD principal investigator
The First Affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants in people with NSCLC and PET/CT, run by The First Affiliated Hospital of Xiamen University 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 0 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Long Sun, PhD (86 0592-2137077, 13178352662@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiomic feature selection and model establishment (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2020.