- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04007068
FDG PET/CT Radiomics Analyses of Lung Cancer Patients Treated With Immunotherapy
July 1, 2019 updated by: Institute of Oncology Ljubljana
We propose iRADIOMICS, a highly innovative and potentially clinical practice changing tool, which will allow for better management of patients undergoing immunotherapy.
iRADIOMICS is based on in-depth interrogation of the molecular imaging (FDG PET/CT) data, extracting "invisible" information based on physical description of the imaging information.
Based on the promising preliminary results of our pilot study, we hypothesise that radiomics analyses of FDG PET/CT scans of patients treated with immunotherapy (iRADIOMICS) can better predict response to immunotherapy compared to the current standards (iRC).
iRADIOMICS will be assessed in a prospective clinical study, involving 30 patients with metastatic non-small-cell lung cancer, treated with anti-programmed death-1 (anti-PD1) antibodies.
Patients will undergo FDG PET/CT before the administration of anti-PD-1, at 1 month and 4 months after the administration.
Afterwards, the patients will be imaged with FDG PET/CT every 6 months.
Additionally, the patients will undergo diagnostic CT scan every 3 months to allow for comparison to the current standard (irRC).
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
We hypothesise that molecular imaging-based RADIOMICS analysis of FDG PET/CT data (termed iRADIOMICS) provides more information than standard anatomical imaging-based irRC analysis regarding the assessment of the effectiveness of immunotherapy and will have a stronger predictive power.
It is widely accepted that molecular imaging (e.g.
PET/CT) reflects changes in tissues much sooner than anatomical imaging (CT, MRI).
Therefore, we expect that an immunotherapy assessment tool based on FDG PET/CT should outperform anatomical-imaging-based irRC also timewise.
Although we do expect an initial increase in FDG PET uptake (mainly due to the metabolic activity of tumour infiltrating lymphocytes (TILs)), followed by a late decrease, we argue that the predictive power of FDG PET can be even further increased by including an in-depth analysis of additional imaging features - the aforementioned "radiomics texture features".
Many studies across different types of cancer have found a correlation between the presence of TILs and patient survival.
Therefore we expect that iRADIOMICS signature of responders will be different from the irRADIOMICS signature of non-responders to antiPD1 immunotherapy due to the different levels of TILs infiltration, different TILs spatial distribution within the tumour, and different composition of immunosuppressive tumour microenvironment containing different levels and spatial distribution of various immunosuppressive cells, such as myeloid-derived suppressive cells (MDSC), regulatory T cells (Treg), tumour-associated macrophages (TAM), regulatory dendritic cells (DCreg) and others 30.
Thus we anticipate that it might be possible to assess the response to immunotherapy at just one imaging time-point, preferably already in the pseudo-progression phase, thus much earlier than with irRC.
Based on the assumption that irRADIOMICS might be able to detect differences in tumour immunosuppressive microenvironment, we further hypothesise that it might be also possible to predict, which patients are most likely to benefit from anti-PD1 immunotherapy already before the therapy.
Study Type
Observational
Enrollment (Anticipated)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ljubljana, Slovenia, 1000
- Institut of oncology Ljubljana
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cytologically or histologically confirmed NSCLC patients with PD-L1 TPS ≥1% in stage IVa, IVb or recurrent NSCLC (classification IASLC, 7th edition, 2009) that are candidates for immunotherapy.
Description
Inclusion Criteria:
- Age ≥ 18 years;
- Cytologically or histologically confirmed NSCLC with PD-L1 TPS ≥1% (confirmed by a validated test);
- Stage IVa, IVb or recurrent NSCLC (classification IASLC, 7th edition, 2009);
- Up to 10 metastases in multiple organ systems, or more than 10 metastases in more than two organ systems;
- No signs of active and/or untreated brain metastases;
- At least three measurable lesions;
- Progression after the first or second-line systemic therapy;
- WHO performance status 0-2 (ECOG criteria);
- Following the decision of multidisciplinary board that the patient is a candidate for treatment with pembrolizumab;
- FDG PET/CT performed up to 4 weeks prior to treatment;
- Performed diagnostic CT scans (thorax and abdomen) up to 4 weeks prior to treatment;
- Signed and dated written informed consent.
Exclusion Criteria:
Symptomatic and/or untreated brain metastases;
- History of other malignancies, except for the following: adequately treated basal or squamous cell carcinoma of the skin, curatively treated in situ carcinoma of the uterine cervix, other curatively treated solid tumour with no evidence of disease for ≥ 3 years;
- All contraindications for treatment with pembrolizumab.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of iRADIOMICS with survival
Time Frame: 1.1.2017 - 31.12.2020
|
To evaluate whether iRADIOMICS predicts response to immunotherapy better than irRC.
|
1.1.2017 - 31.12.2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ANTICIPATED)
July 30, 2019
Study Completion (ANTICIPATED)
December 31, 2020
Study Registration Dates
First Submitted
July 1, 2019
First Submitted That Met QC Criteria
July 1, 2019
First Posted (ACTUAL)
July 5, 2019
Study Record Updates
Last Update Posted (ACTUAL)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 1, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- KME 117/02/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Correlation of iRADIOMICS and irRC With Survival
-
Jingyuan,XuUnknownEvaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDSChina
-
Chun PanUnknownEvaluate the Correlation Between the Level of Mitochondrial DNA in Plasma and the Prognosis of the Patients With ARDS.China
-
University Hospital of North NorwayActive, not recruitingSurvival of the Implants With Revision as Endpoint | Clinical Performance With HHS | Patients Satisfaction With the Hip ImplantNorway
-
Materno-Perinatal Hospital of the State of MexicoUniversidad Autonoma del Estado de Mexico; Ciprés Grupo Médico CGM SCCompletedCorrelation of Cytokines and Anthropometry in PregnancyMexico
-
Peking Union Medical College HospitalOrigiMedRecruitingQuality of Life | Objective Response Rate | Overall Survival | Progression-free Survival | Disease Control Rate | Duration of Response | Five-year Survival RateChina
-
Terumo BCTbioU.S. Army Medical Research and Development CommandCompletedFocus of Study: Radiolabel Recovery and Survival of RBCsUnited States
-
Cairo UniversityActive, not recruitingCorrelation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral PalsyEgypt
-
Sylvestre KABURACompletedGastric Cancer | Mortality of Gastric Cancer | Overall Survival of Patients With Gastric Cancer
-
Beijing Chao Yang HospitalRecruitingLocal Recurrence of Malignant Tumor of Rectum | Circumferential Resection Margin | Intraoperative Perforation of Rectum | Disease-free Survival | Overal SurvivalChina
-
Shree Birendra HospitalBP Koirala Institute of Health SciencesCompletedObstuctive Jaundice | Radiological Correlation of Obstructive JaundiceNepal
Clinical Trials on FDG PET/CT
-
Washington University School of MedicineTerminatedCervical Cancer | Uterine Cervical Neoplasms | Uterine Cervical CancerUnited States
-
University of UtahNational Cancer Institute (NCI)CompletedFluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) in Cancer Associated VenothromboembolismVenothromboembolismUnited States
-
Peter MacCallum Cancer Centre, AustraliaMelbourne Health; Westmead Hospital; Victorian Infectious Diseases Reference...CompletedAcute Myeloid Leukemia | Febrile Neutropenia | Acute Lymphoblastic Leukemia | Haematopoietic Stem Cell Transplant, Autologous | Haematopoietic Stem Cell Transplant, AllogeneicAustralia
-
Region VästerbottenUmeå UniversityRecruitingCervix Cancer | Endometrial Cancer | Epithelial Ovarian CancerSweden
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedMalignant Neoplasm of Breast TNM Staging Distant Metastasis (M) | Untreated Bone MetastasesUnited States
-
Abramson Cancer Center at Penn MedicineActive, not recruiting
-
University of ZurichWithdrawnAdenocarcinoma | Stomach Cancer | Cancer of Esophagogastric JunctionSwitzerland
-
Rabin Medical CenterUnknown
-
Jewish General HospitalRecruitingVasculitis | Giant Cell ArteritisCanada