Non-small Cell Lung CancerNCT04007068
FDG PET/CT Radiomics Analyses of Lung Cancer Patients Treated With Immunotherapy
An observational study of Non-small Cell Lung Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
The investigators propose iRADIOMICS, a highly innovative and potentially clinical practice changing tool, which will allow for better management of patients undergoing immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- FDG PET/CT
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2017to 31 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators 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, the investigators 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).
Read the detailed description
The investigators 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, the investigators expect that an immunotherapy assessment tool based on FDG PET/CT should outperform anatomical-imaging-based irRC also timewise. Although the investigators 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, the investigators 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 the investigators 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 the investigators 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, the investiagators 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- FDG PET/CT
- Keywords
- RADIOMICS ANALYSIS
- 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.
FDG PET/CTDiagnostic test
FDG PET/CT baseline, month 1, month 4, month 10, than every 6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of iRADIOMICS with survival
To evaluate whether iRADIOMICS predicts response to immunotherapy better than irRC.
Measured: 1.1.2017 - 31.12.2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Jan 2017
- Primary completion30 Mar 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007068
- Sponsor's protocol ID
- KME 117/02/17
- Status last verified
- Oct 2024
- First submitted
- 1 Jul 2019
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG PET/CT Radiomics Analyses of Lung Cancer Patients Treated With Immunotherapy
- ClinicalTrials.gov ID
- NCT04007068
- Acronym / sponsor ID
- KME 117/02/17
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- RADIOMICS ANALYSIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 5 Jul 2019 (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.
The investigators 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, the investigators 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).
Detailed description
The investigators 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, the investigators expect that an immunotherapy assessment tool based on FDG PET/CT should outperform anatomical-imaging-based irRC also timewise. Although the investigators 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, the investigators 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 the investigators 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 the investigators 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, the investiagators 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| FDG PET/CTFDG PET/CT baseline, month 1, month 4, month 10, than every 6 months | Diagnostic test | – |
Primary outcome
Correlation of iRADIOMICS with survival
Time frame: 1.1.2017 - 31.12.2020
To evaluate whether iRADIOMICS predicts response to immunotherapy better than irRC.
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 18 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer
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
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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 Non-small Cell Lung Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 12 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: finished, as of the sponsor's last update on 18 Oct 2024. 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 Slovenia. 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?
Correlation of iRADIOMICS with survival (time frame: 1.1.2017 - 31.12.2020). 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 18 Oct 2024.