Carcinoma, Non-Small-Cell LungIBFICNCT05260606
Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer
An observational study of Carcinoma, Non-Small-Cell Lung and Immune Checkpoint Inhibitors, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
1. Hypothesis : imaging biomarkers of tumor measured by F-18 fluorodeoxyglucose (FDG) positron emission tomography(PET)/computed tomography(CT) is correlated with immune checkpoint inhibitor (ICI) treatment response and patient prognosis. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Immune Checkpoint Inhibitors
- What is being tested?
- F-18 FDG PET/CT
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2022to Dec 2025
- How long will I take part?
- 2 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years old or over with non-small cell lung cancer who will be treated with immune checkpoint inhibitors
Who may be able to join
- 18 years old or over
- pathologically proven non-small cell lung cancer: adenocarcinoma or squamous cell carcinoma
- patients to be treated with immune checkpoint inhibitors (nivolumab or pembrolizumab or atezolizumab)
- ECOG performance status ≤ 2
- A person who have heard the detailed explanation of this clinical trial and are willing to voluntarily decide to participate and sign the informed consent form
Who cannot join
- subjects without measurable lesion: They must have at least one measurable lesion with a diameter of 10 mm by spiral CT or multi-detector CT (MD CT) or 20 mm or larger by conventional CT.
- subjects with a history of other malignant diseases within the past 5 years, except for treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, cured thyroid cancer, and early gastric cancer
- subjects with clinically significant uncontrolled seizures, central nervous system disease, or psychiatric disorders that, in the investigator's judgment, interferes with or is likely to interfere with the understanding of informed consent
- subjects with uncontrolled diabetes
- subjects with severe uncontrolled infection
- subjects who underwent major surgery within 4 weeks prior to the start of the clinical trial or who have not fully recovered from the effects of major surgery
Show all 9Show fewer
- pregnant or lactating patients
- subjects who have not received a pregnancy test or have a positive result during the basic test (menopause women with amenorrhea period of at least 12 months or longer are considered infertile subjects)
- women or men of childbearing potential who are unwilling to use contraception during the clinical trial period
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Seung hwan Moon, MD., Ph.D., +82-2-3410-6293, seunghwan.moons.moon@samsung.com
About this study
Official title: Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer: Prospective Observational Study
- Hypothesis : imaging biomarkers of tumor measured by F-18 fluorodeoxyglucose (FDG) positron emission tomography(PET)/computed tomography(CT) is correlated with immune checkpoint inhibitor (ICI) treatment response and patient prognosis.
- Purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and clinical outcomes in patients with non-small cell lung cancer treated with ICIs.
- Study subject: patients with non-small cell lung cancer who will be treated with ICIs.
- Study design: prospective observational study
- Intervention: F-18 FDG PET/CT
Read the detailed description
- Study purposes
- Primary purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and treatment response in non-small cell lung cancer (NSCLC) patients treated with ICIs.
- Secondary purpose: To evaluate the association between PET imaging parameters, patient prognosis, CT imaging parameters, and other biomarkers, and to compare treatment response evaluation criteria.
- Background: development of ICIs opened a new paradigm for cancer treatment. It enables long-term survival of patients with advanced cancers, which could not be expected to be effective with conventional chemotherapy. Therapeutic response and prognosis to ICIs have unique characteristics which are different from those of conventional cytotoxic or targeted therapies. Even if the initial response rate is not high, if the treatment effect is effective, the effect is long-lasting and enabling long-term survival. With the evaluation criteria based on the change in tumor size, it is difficult to differentiate between an atypical response of ICIs and disease progression. Therefore, a new type of approach is required. F-18 FDG PET/CT is an imaging method that is currently used for many cancers. In recent studies on the response evaluation of ICIs using FDG PET/CT, FDG PET/CT has shown potential as a predictive tool of therapeutic response and prognosis. However, despite the potential, most of the related studies are retrospective design and small in scale. Additionally, it is not known which PET imaging features are suitable for predicting treatment response and prognosis. A novel image analysis method based on image informatics has been tried. After extracting image features from imaging modalities such as PET, CT, MRI, they are fused with clinical information and genetic information and analyzed through an artificial intelligence-based platform. It has been reported that a predictive model based on CT image features can predict the treatment response to ICI. However, the efficacy of imaging biomarkers for predicting ICI treatment response has not yet been proven, and further prospective studies are needed. Therefore, patients with NSCLC to be treated with ICI will receive FDG PET/CT before and during treatment in this study. In addition, PET images will be comprehensively analyzed together with other image data, biomarkers, and clinical data, and will be used as basic data for future ICI prediction models.
- Study design: single institution, single-arm, prospective observational study
- Study population: NSCLC patients who are scheduled to receive ICI in our institution
- Recruitment: clinical referrals
- Target number: 100 patients available for analysis.
- Intervention: F-18 FDG PET/CT scan
- Study protocol
- Study participants will have FDG PET/CT before and during ICI Tx.
- There is no difference from the treatment schedule performed in usual clinical setting except for an additional F-18 FDG PET/CT scan. Detailed plan of ICI treatment and patient management (dose, administration date, treatment period, and follow-up) follows the standard protocol of our institution in this study.
- Scans: 1st scan (pre-treatment), 2nd scan (interim), 3rd scan (Optional)
- Variables
- Death status, date of death
- Disease progression status, date of disease progression
- ICI type and dose
- First day of ICI treatment, end day of ICI treatment, ICI treatment cycle
- Hospital visit dates
- Neutrophil to lymphocyte ratio (NLR)
- Immunochemical staining results [PD-L1: Combined positive score (CPS) and tumor proportion score (TPS)]
- Other blood and biopsy results
- FDG PET/CT imaging parameters [Standard uptake value (SUV)max, SUVpeak, metabolic tumor volume (MTV), total lesion glycolysis (TLG), spleen to liver ratio (SLR), etc]
- CT imaging parameters
- PET-based treatment response: positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria/ immune PERCIST (iPERCIST)/ Deauville score
- CT-based treatment response: response Criteria in Solid Tumors (RECIST v1.1) criteria / immune RECIST (iRECIST) criteria / immune-modified RECIST (imRECIST)
- Being tested
- F-18 FDG PET/CT
- 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.
F-18 FDG PET/CTDiagnostic test
- 1st scan: pre-Tx, ICI Tx must be started within 35 days after 1st scan.
- 2nd scan: interim
- Pembrolizumab or atezolizumab: after the 2nd Tx cycle to before the start of the 3rd Tx cycle
- Nivolumab: after the 3rd Tx cycle to before the start of the 4th Tx cycle
- 3rd scan: optional (3rd scan can be performed when disease progression is suspected)
- Imaging
- Fasting: at least 6 hours
- Blood glucose level: < 200 mg/dL
- F-18 FDG 0.14 mCi/kg (IV)
- Image acquisition: 1 hr after FDG injection, CT images are acquired. After CT scan, PET images are acquired and attenuation-corrected PET images are reconstructed based on the CT image data.
- PET/CT: Discovery MIDR or MI (GE Healthcare, Chicago, Illinois, USA)
- First and second scans have to be performed with same scan.
| Study group | Role | What they receive |
|---|---|---|
| Patients with NSCLC who will have FDG PET/CT before and during ICI Tx | There is no difference from the treatment schedule performed in usual clinical setting except for an additional F-18 FDG PET/CT scan. Detailed plan of ICI treatment and patient management (dose, administration date, treatment period, and follow-up) follows the standard protocol of our institution in this study. Receives: Diagnostic Test: F-18 FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between metabolic imaging parameters and treatment response
- Analyze the correlation between metabolic imaging indicators (SUVmax, SULpeak, MTV, TLG, SLR of tumor lesions on 1st scan, % change of SUVmax, % change of SULpeak, % change of MTV, % change of TLG, % change of SLR between 1st and 2nd scans) and treatment response.
- Treatment response: If the patient maintains a stable disease state or above based on the CT response evaluation criteria for more than 6 months, it is considered to have a response.
- % change = [((Value of SCAN2 - value of SCAN1)/value of SCAN1) X 100]
- Analysis model: point-biserial correlation analysis (Two-tailed test)
Measured: The primary analysis can be performed when all study subjects have elapsed more than 6 months after the start of treatment.
Secondary outcomes (7)
Correlation between metabolic imaging parameters and patient prognosis
- Analyze the correlation between the metabolic imaging indicators and patient's overall survival (OS) and progression free survival (PFS) using Cox proportional hazard model
Measured: The primary analysis can be performed when all study subjects have elapsed more than 12 months after the start of treatment.
Comparison of clinical outcome according to FDG PET/CT evaluation criteria (PERCIST vs. iPERCIST)
- Compare clinical outcome according to the FDG PET/CT evaluation criteria (PERCIST vs. iPERCIST) using Pearson chi-square test
Measured: The primary analysis can be performed when all study subjects have elapsed more than 12 months after the start of treatment.
Correlation between metabolic imaging parameters and CT imaging parameters obtained from contrast-enhanced CT
- Analyze the correlation between PET parameters and contrast CT parameters using Pearson or Spearman correlation analysis
Measured: Analysis can be performed at the time when all target subjects underwent pre-treatment and interim F-18 FDG PET/CT scans.
Comparison of FDG PET/CT evaluation criteria with CT evaluation criteria (iRECIST and imRECIST)
- Compare FDG PET/CT evaluation criteria and CT evaluation criteria using Pearson chi-square test
Measured: Analysis can be performed at the time when all target subjects underwent pre-treatment and interim F-18 FDG PET/CT scans.
Correlation between imaging markers and non-imaging biomarkers
- Analyze correlation between imaging parameters and non-imaging biomarker such as NLR using Pearson or Spearman correlation analysis/ biserial correlation analysis
Measured: Analysis can be performed at the time when all target subjects underwent pre-treatment and interim F-18 FDG PET/CT scans.
Correlation between biomarkers and treatment response
- Analyze correlation between biomarkers and treatment response using Point-biserial correlation analysis
Measured: The primary analysis can be performed when all study subjects have elapsed more than 6 months after the start of treatment.
Correlation between biomarkers and patient prognosis
- Analyze the correlation between biomarkers and prognosis (OS, PFS) using Cox proportional hazard model
Measured: The primary analysis can be performed when all study subjects have elapsed more than 12 months after the start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start9 May 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Yun Lee, Samsung Medical Center
- Investigators
- hoyun lee, M.D., Ph.D., Principal investigator, Samsung Medical Center, Department radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260606
- Sponsor's protocol ID
- SMO1220071
- Acronym
- IBFIC
- Status last verified
- Apr 2024
- First submitted
- 18 Feb 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Takada K, Toyokawa G, Yoneshima Y, Tanaka K, Okamoto I, Shimokawa M, Wakasu S, Haro A, Osoegawa A, Tagawa T, Oda Y, Nakanishi Y, Mori M. 18F-FDG uptake in PET/CT is a potential predictive biomarker of response to anti-PD-1 antibody therapy in non-small cell lung cancer. Sci Rep. 2019 Sep 16;9(1):13362. doi: 10.1038/s41598-019-50079-2.
PubMed 31527660Goldfarb L, Duchemann B, Chouahnia K, Zelek L, Soussan M. Monitoring anti-PD-1-based immunotherapy in non-small cell lung cancer with FDG PET: introduction of iPERCIST. EJNMMI Res. 2019 Jan 29;9(1):8. doi: 10.1186/s13550-019-0473-1.
PubMed 30694399Humbert O, Cadour N, Paquet M, Schiappa R, Poudenx M, Chardin D, Borchiellini D, Benisvy D, Ouvrier MJ, Zwarthoed C, Schiazza A, Ilie M, Ghalloussi H, Koulibaly PM, Darcourt J, Otto J. 18FDG PET/CT in the early assessment of non-small cell lung cancer response to immunotherapy: frequency and clinical significance of atypical evolutive patterns. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1158-1167. doi: 10.1007/s00259-019-04573-4. Epub 2019 Nov 23.
PubMed 31760467Seban RD, Mezquita L, Berenbaum A, Dercle L, Botticella A, Le Pechoux C, Caramella C, Deutsch E, Grimaldi S, Adam J, Ammari S, Planchard D, Leboulleux S, Besse B. Baseline metabolic tumor burden on FDG PET/CT scans predicts outcome in advanced NSCLC patients treated with immune checkpoint inhibitors. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1147-1157. doi: 10.1007/s00259-019-04615-x. Epub 2019 Nov 21.
PubMed 31754795
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer: Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05260606
- Acronym / sponsor ID
- IBFIC / SMO1220071
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Mar 2022 (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.
- Hypothesis : imaging biomarkers of tumor measured by F-18 fluorodeoxyglucose (FDG) positron emission tomography(PET)/computed tomography(CT) is correlated with immune checkpoint inhibitor (ICI) treatment response and patient prognosis.
- Purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and clinical outcomes in patients with non-small cell lung cancer treated with ICIs.
- Study subject: patients with non-small cell lung cancer who will be treated with ICIs.
- Study design: prospective observational study
- Intervention: F-18 FDG PET/CT
Detailed description
- Study purposes
- Primary purpose: To evaluate the association between metabolic imaging parameters measured by F-18 FDG PET/CT and treatment response in non-small cell lung cancer (NSCLC) patients treated with ICIs.
- Secondary purpose: To evaluate the association between PET imaging parameters, patient prognosis, CT imaging parameters, and other biomarkers, and to compare treatment response evaluation criteria.
- Background: development of ICIs opened a new paradigm for cancer treatment. It enables long-term survival of patients with advanced cancers, which could not be expected to be effective with conventional chemotherapy. Therapeutic response and prognosis to ICIs have unique characteristics which are different from those of conventional cytotoxic or targeted therapies. Even if the initial response rate is not high, if the treatment effect is effective, the effect is long-lasting and enabling long-term survival. With the evaluation criteria based on the change in tumor size, it is difficult to differentiate between an atypical response of ICIs and disease progression. Therefore, a new type of approach is required. F-18 FDG PET/CT is an imaging method that is currently used for many cancers. In recent studies on the response evaluation of ICIs using FDG PET/CT, FDG PET/CT has shown potential as a predictive tool of therapeutic response and prognosis. However, despite the potential, most of the related studies are retrospective design and small in scale. Additionally, it is not known which PET imaging features are suitable for predicting treatment response and prognosis. A novel image analysis method based on image informatics has been tried. After extracting image features from imaging modalities such as PET, CT, MRI, they are fused with clinical information and genetic information and analyzed through an artificial intelligence-based platform. It has been reported that a predictive model based on CT image features can predict the treatment response to ICI. However, the efficacy of imaging biomarkers for predicting ICI treatment response has not yet been proven, and further prospective studies are needed. Therefore, patients with NSCLC to be treated with ICI will receive FDG PET/CT before and during treatment in this study. In addition, PET images will be comprehensively analyzed together with other image data, biomarkers, and clinical data, and will be used as basic data for future ICI prediction models.
- Study design: single institution, single-arm, prospective observational study
- Study population: NSCLC patients who are scheduled to receive ICI in our institution
- Recruitment: clinical referrals
- Target number: 100 patients available for analysis.
- Intervention: F-18 FDG PET/CT scan
- Study protocol
- Study participants will have FDG PET/CT before and during ICI Tx.
- There is no difference from the treatment schedule performed in usual clinical setting except for an additional F-18 FDG PET/CT scan. Detailed plan of ICI treatment and patient management (dose, administration date, treatment period, and follow-up) follows the standard protocol of our institution in this study.
- Scans: 1st scan (pre-treatment), 2nd scan (interim), 3rd scan (Optional)
- Variables
- Death status, date of death
- Disease progression status, date of disease progression
- ICI type and dose
- First day of ICI treatment, end day of ICI treatment, ICI treatment cycle
- Hospital visit dates
- Neutrophil to lymphocyte ratio (NLR)
- Immunochemical staining results [PD-L1: Combined positive score (CPS) and tumor proportion score (TPS)]
- Other blood and biopsy results
- FDG PET/CT imaging parameters [Standard uptake value (SUV)max, SUVpeak, metabolic tumor volume (MTV), total lesion glycolysis (TLG), spleen to liver ratio (SLR), etc]
- CT imaging parameters
- PET-based treatment response: positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria/ immune PERCIST (iPERCIST)/ Deauville score
- CT-based treatment response: response Criteria in Solid Tumors (RECIST v1.1) criteria / immune RECIST (iRECIST) criteria / immune-modified RECIST (imRECIST)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with NSCLC who will have FDG PET/CT before and during ICI Tx | – | Diagnostic Test: F-18 FDG PET/CTThere is no difference from the treatment schedule performed in usual clinical setting except for an additional F-18 FDG PET/CT scan. Detailed plan of ICI treatment and patient management (dose, administration date, treatment period, and follow-up) follows the standard protocol of our institution in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years old or over with non-small cell lung cancer who will be treated with immune checkpoint inhibitors
Key inclusion criteria (5 listed)
- 18 years old or over
- pathologically proven non-small cell lung cancer: adenocarcinoma or squamous cell carcinoma
- patients to be treated with immune checkpoint inhibitors (nivolumab or pembrolizumab or atezolizumab)
- ECOG performance status ≤ 2
- A person who have heard the detailed explanation of this clinical trial and are willing to voluntarily decide to participate and sign the informed consent form
Key exclusion criteria (9 listed)
- subjects without measurable lesion: They must have at least one measurable lesion with a diameter of 10 mm by spiral CT or multi-detector CT (MD CT) or 20 mm or larger by conventional CT.
- subjects with a history of other malignant diseases within the past 5 years, except for treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, cured thyroid cancer, and early gastric cancer
- subjects with clinically significant uncontrolled seizures, central nervous system disease, or psychiatric disorders that, in the investigator's judgment, interferes with or is likely to interfere with the understanding of informed consent
- subjects with uncontrolled diabetes
- subjects with severe uncontrolled infection
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 |
|---|---|---|
| F-18 FDG PET/CT1. 1st scan: pre-Tx, ICI Tx must be started within 35 days after 1st scan. 2. 2nd scan: interim * Pembrolizumab or atezolizumab: after the 2nd Tx cycle to before the start of the 3rd Tx cycle * Nivolumab: after the 3rd Tx cycle to before the start of the 4th Tx cycle 3. 3rd scan: optional (3rd scan can be performed when disease progression is suspected) 4. Imaging * Fasting: at least 6 hours * Blood glucose level: < 200 mg/dL * F-18 FDG 0.14 mCi/kg (IV) * Image acquisition: 1 hr after FDG injection, CT images are acquired. After CT scan, PET images are acquired and attenuation-corrected PET images are reconstructed based on the CT image data. * PET/CT: Discovery MIDR or MI (GE Healthcare, Chicago, Illinois, USA) * First and second scans have to be performed with same scan. | Diagnostic test | Patients with NSCLC who will have FDG PET/CT before and during ICI Tx |
Primary outcome
Correlation between metabolic imaging parameters and treatment response
Time frame: The primary analysis can be performed when all study subjects have elapsed more than 6 months after the start of treatment.
* Analyze the correlation between metabolic imaging indicators (SUVmax, SULpeak, MTV, TLG, SLR of tumor lesions on 1st scan, % change of SUVmax, % change of SULpeak, % change of MTV, % change of TLG, % change of SLR between 1st and 2nd scans) and treatment response. * Treatment response: If the patient maintains a stable disease state or above based on the CT response evaluation criteria for more than 6 months, it is considered to have a response. * % change = [((Value of SCAN2 - value of SCAN1)/value of SCAN1) X 100] * Analysis model: point-biserial correlation analysis (Two-tailed test)
7 secondary outcomes
Correlation between metabolic imaging parameters and patient prognosis
Time frame: The primary analysis can be performed when all study subjects have elapsed more than 12 months after the start of treatment.
Comparison of clinical outcome according to FDG PET/CT evaluation criteria (PERCIST vs. iPERCIST)
Time frame: The primary analysis can be performed when all study subjects have elapsed more than 12 months after the start of treatment.
Correlation between metabolic imaging parameters and CT imaging parameters obtained from contrast-enhanced CT
Time frame: Analysis can be performed at the time when all target subjects underwent pre-treatment and interim F-18 FDG PET/CT scans.
Comparison of FDG PET/CT evaluation criteria with CT evaluation criteria (iRECIST and imRECIST)
Time frame: Analysis can be performed at the time when all target subjects underwent pre-treatment and interim F-18 FDG PET/CT scans.
Correlation between imaging markers and non-imaging biomarkers
Time frame: Analysis can be performed at the time when all target subjects underwent pre-treatment and interim F-18 FDG PET/CT scans.
Correlation between biomarkers and treatment response
Time frame: The primary analysis can be performed when all study subjects have elapsed more than 6 months after the start of treatment.
Correlation between biomarkers and patient prognosis
Time frame: The primary analysis can be performed when all study subjects have elapsed more than 12 months after the start of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 31527660Takada K, Toyokawa G, Yoneshima Y, Tanaka K, Okamoto I, Shimokawa M, Wakasu S, Haro A, Osoegawa A, Tagawa T, Oda Y, Nakanishi Y, Mori M. 18F-FDG uptake in PET/CT is a potential predictive biomarker of response to anti-PD-1 antibody therapy in non-small cell lung cancer. Sci Rep. 2019 Sep 16;9(1):13362. doi: 10.1038/s41598-019-50079-2.
- Background: PubMed 30694399Goldfarb L, Duchemann B, Chouahnia K, Zelek L, Soussan M. Monitoring anti-PD-1-based immunotherapy in non-small cell lung cancer with FDG PET: introduction of iPERCIST. EJNMMI Res. 2019 Jan 29;9(1):8. doi: 10.1186/s13550-019-0473-1.
- Background: PubMed 31760467Humbert O, Cadour N, Paquet M, Schiappa R, Poudenx M, Chardin D, Borchiellini D, Benisvy D, Ouvrier MJ, Zwarthoed C, Schiazza A, Ilie M, Ghalloussi H, Koulibaly PM, Darcourt J, Otto J. 18FDG PET/CT in the early assessment of non-small cell lung cancer response to immunotherapy: frequency and clinical significance of atypical evolutive patterns. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1158-1167. doi: 10.1007/s00259-019-04573-4. Epub 2019 Nov 23.
- Background: PubMed 31754795Seban RD, Mezquita L, Berenbaum A, Dercle L, Botticella A, Le Pechoux C, Caramella C, Deutsch E, Grimaldi S, Adam J, Ammari S, Planchard D, Leboulleux S, Besse B. Baseline metabolic tumor burden on FDG PET/CT scans predicts outcome in advanced NSCLC patients treated with immune checkpoint inhibitors. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1147-1157. doi: 10.1007/s00259-019-04615-x. Epub 2019 Nov 21.
- Individual participant dataSharing planned: Undecided
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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.
hoyun lee, M.D., Ph.D. principal investigator
Samsung Medical Center, Department radiology
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 Carcinoma, Non-Small-Cell Lung and Immune Checkpoint Inhibitors, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 9 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 Apr 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 South Korea. 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 Seung hwan Moon, M.D., Ph.D. (+82-2-3410-6293, seunghwan.moons.moon@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between metabolic imaging parameters and treatment response (time frame: The primary analysis can be performed when all study subjects have elapsed more than 6 months after the start of treatment.). 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 NCT05260606, which also lists 4 linked publications.
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 Apr 2024.