Molecular Imaging Visualization of Tumor Heterogeneity in Non-small Cell Lung Cancer
11 september 2020 uppdaterad av: The First Affiliated Hospital of Xiamen University
To assess the potential usefulness of radiogenomics for tumor driving genes heterogeneity in non-small cell lung cancer.
Studieöversikt
Status
Okänd
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
150
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Fujian
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XiaMen, Fujian, Kina, 0086-361000
- Rekrytering
- First Affiliated Hospital of Xiamen University
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Kontakt:
- Long Sun, doctor
- Telefonnummer: 86 0592-2137077
- E-post: 13178352662@163.com
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Criteria: Inclusion Criteria:
- (i) adult patients (aged 18 years or order);
- (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
- (iii) patients who had scheduled both 18F-FDG PET/CT scans and PET/CT guided biopsy;
- (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion Criteria:
- (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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 8F-FDG PET/CT and PET/CT-guide targeted biopsy
Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time.
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Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Radiomic feature selection and model establishment
Tidsram: 3 years
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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.
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3 years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Genes mutation detection
Tidsram: 30 days
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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.
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30 days
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Image acquisition
Tidsram: 30 days
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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.
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30 days
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Radiomic feature extraction
Tidsram: 30 days
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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.
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30 days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Long Sun, PhD, The First Affiliated Hospital of Xiamen University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 oktober 2019
Primärt slutförande (Förväntat)
1 oktober 2022
Avslutad studie (Förväntat)
1 oktober 2022
Studieregistreringsdatum
Först inskickad
30 juli 2020
Först inskickad som uppfyllde QC-kriterierna
11 september 2020
Första postat (Faktisk)
17 september 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 september 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 september 2020
Senast verifierad
1 juli 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KYH2019-039
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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