MelanomaNCT06207747
Quantitative Analysis of PET/CT Images of Immune Related Side Effects in Metastatic Melanoma Patients
A study testing additional PET/CT at 4 weeks, analysing using quantative analysis in people with Melanoma and PET CT, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
New cancer treatment with immune-checkpoint inhibitors (ICIs) has changed the way patients with melanoma and a variety of other cancers are being treated. Many pivotal trials that showed efficacy and safety of ICIs were performed in malignant melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- additional PET/CT at 4 weeks, analysing using quantative analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Sep 2020to 10 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Older than 18 years old
- Cyto- or histologically proven melanoma
- Stage III.D unresectable/ stage IV melanoma (AJCC classification, 8th edition, 2018)
- Asymptomatic brain metastases
- Three measurable metastatic lesions
- 1st, 2nd, further line of systemic treatment with ICIs (either ipilimumab, nivolumab, pembrolizumab, or combination)
Show all 9Show fewer
- PS WHO 0-2 (ECOG criteria)
- FDG-PET within four weeks of treatment initiation
- Written consent form
Who cannot join
- Symptomatic brain metastases
- PS WHO \> 2 (ECOG criteria)
- Contraindications for ICI treatment
- Other malignant diseases (not included: BCC, SCC, in situ carcinoma of cervix, other cured malignant diseases without relapse more than three years)
Trial locations and contacts
1 site in 1 country.
About this study
New cancer treatment with immune-checkpoint inhibitors (ICIs) has changed the way patients with melanoma and a variety of other cancers are being treated. Many pivotal trials that showed efficacy and safety of ICIs were performed in malignant melanoma. ICI can cause a different type of toxicity, called immune-related adverse events (irAEs). Though the exact pathophysiology is not completely understood, it is believed that irAEs are provoked by immune upregulation and inflammation. However, they can be serious, life-threatening, and warrant hospital admission as well. Dangerous irAEs include myocarditis, myositis, and pneumonitis, among others. Due to the novel mechanism of action, unpredictable nature, and wide usage of this type of treatment in the future, there is urgent need for better control of these potentially dangerous side effects. Early recognition and treatment of irAEs are of great importance in successful management.
Positron emission tomography-computed tomography (PET/CT) with [18F]2fluoro-2-deoxy-D-glucose (18F-FDG) is a sensitive, non-invasive, and widely used method for diagnosis and evaluation of treatment efficacy of malignant melanoma. The combination of 18F-FDG-PET and CT allows for assessment of both functional and morphological status of the lesions, and so facilitates better clinical decisions and patient care during treatment. It is also a very sensitive method for recognising inflammation, that can be a signal of irAEs.
Read more
Quantitative analysis is a rapidly evolving field of PET/CT image analysis. It includes both radiomics and artificial intelligence. Some studies have reported that quantitative analysis could predict efficacy of different cancer treatments. Quantitative image analysis in cancer response assessment is a rapidly expanding field, with the ultimate goal of clinical translation. However, in the specific instance of irAE diagnosis, it is not yet clear what role quantitative analysis of PET/CT scans can play.
The hypothesis is that quantitative analysis of PET/CT images provides more information on possible irAE, thus helping to treat these side effects more quickly and successfully.
Read the detailed description
New cancer treatment with immune-checkpoint inhibitors (ICIs) has changed the way patients with melanoma and a variety of other cancers are being treated. Based on many positive randomised controlled trials in metastatic and neo-/adjuvant setting, ICI agents targeting programmed death-1 (PD-1), programmed death ligand-1 (PD-L1) and cytotoxic T-lymphocyte antigen-4 (CTLA-4) have become invaluable in the treatment of different carcinomas. Many pivotal trials that showed efficacy and safety of ICIs were performed in malignant melanoma.
ICI can cause a different type of toxicity, called immune-related adverse events (irAEs), that can occur in any organ of the body. Though the exact pathophysiology is not completely understood, it is believed that irAEs are provoked by immune upregulation and inflammation. In general, they are less frequent compared to chemotherapy toxicities and usually low grade and manageable. However, they can be serious, life-threatening, and warrant hospital admission as well. Dangerous irAEs include myocarditis, myositis, and pneumonitis, among others. Due to the novel mechanism of action, unpredictable nature, and wide usage of this type of treatment in the future, there is urgent need for better control of these potentially dangerous side effects. Early recognition and treatment of irAEs are of great importance in successful management.
Positron emission tomography-computed tomography (PET/CT) with [18F]2fluoro-2-deoxy-D-glucose (18F-FDG) is a sensitive, non-invasive, and widely used method for diagnosis and evaluation of treatment efficacy of malignant melanoma. The combination of 18F-FDG-PET and CT allows for assessment of both functional and morphological status of the lesions, and so facilitates better clinical decisions and patient care during treatment. It is also a very sensitive method for recognising inflammation, that can be a signal of irAEs.
Quantitative analysis is a rapidly evolving field of PET/CT image analysis. It includes both radiomics and artificial intelligence. Quantitative analyses of medical images provide insight into hidden information about the image, which is usually not fully assessed by a nuclear medicine specialist (for example, information on the spatial heterogeneity of the tumour). Some studies have reported that quantitative analysis could predict efficacy of different cancer treatments. Quantitative image analysis in cancer response assessment is a rapidly expanding field, with the ultimate goal of clinical translation. However, in the specific instance of irAE diagnosis, it is not yet clear what role quantitative analysis of PET/CT scans can play.
The hypothesis is that quantitative analysis of PET/CT images provides more information on possible irAE, thus helping to treat these side effects more quickly and successfully. The association of quantitative PET/CT analysis with patient survival and the predictive value of an early-time point PET/CT scan in response to ICIs will be prospectively examined. The positive impact or irAE of autoimmune thyroiditis on the outcome of ICIs treatment will be also will be also evaluated.
- Being tested
- additional PET/CT at 4 weeks, analysing using quantative analysis
- Keywords
- PET/CT, melanoma, immunotherapy, side-effects
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional PET/CT at 4 weeks, analysing using quantative analysisDiagnostic test
Patient with metastatic melanoma will be monitored with additional PET/CT at 4 weeks, analysing using quantative analysis will be done.
| Study group | Role | What they receive |
|---|---|---|
| This study will prospectively collect data from metastatic or stage III.D unresectable melanoma pts | Experimental | Timing of PET/CT scans:
* Baseline PET/CT less than 4 weeks before first ICI infusion
* Follow-up: 4 weeks (+/- 5 days) after first infusion, 16 weeks (+/- 7 days) after first infusion, then after every 16 weeks (+/- 7 days) or before in case of PD suspicion Receives: Diagnostic Test: additional PET/CT at 4 weeks, analysing using quantative analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive value of PET/CT for detecting irAE
PET/CT will be performed regularly in metastatic melanoma patients treated with ICIs. Imaging will be analysed for detection of irAE, using in-depth radiological (nuclear) and quantitative (radiomic and artificial intelligence) analysis of affected organs. SUV percentiles of 18F-FDG uptake in the affected organs will be used for prediction of irAE.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Sep 2020
- Primary completion1 Sep 2023
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will prospectively collect data from metastatic or stage III.D unresectable melanoma patients treated with ICIs and followed regularly with 18F-FDG PET/CT scans. Recruitment is expected to last 18 months. Predictive sample size is 100 melanoma patients. Timing of PET/CT scans: * Baseline PET/CT less than 4 weeks before first ICI infusion * Follow-up: 4 weeks (+/- 5 days) after first infusion, 16 weeks (+/- 7 days) after first infusion, then after every 16 weeks (+/- 7 days) or before in case of PD suspicion .
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nežka Hribernik, M.D., Principal investigator, Institute of Oncology Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207747
- Sponsor's protocol ID
- KME RS 0120-256/2020-14
- Status last verified
- Nov 2023
- First submitted
- 28 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hribernik N, Huff DT, Studen A, Zevnik K, Klanecek Z, Emamekhoo H, Skalic K, Jeraj R, Rebersek M. Quantitative imaging biomarkers of immune-related adverse events in immune-checkpoint blockade-treated metastatic melanoma patients: a pilot study. Eur J Nucl Med Mol Imaging. 2022 May;49(6):1857-1869. doi: 10.1007/s00259-021-05650-3. Epub 2021 Dec 27.
PubMed 34958422Huff DT, Ferjancic P, Namias M, Emamekhoo H, Perlman SB, Jeraj R. Image intensity histograms as imaging biomarkers: application to immune-related colitis. Biomed Phys Eng Express. 2021 Sep 30;7(6):10.1088/2057-1976/ac27c3. doi: 10.1088/2057-1976/ac27c3.
PubMed 34534974
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Analysis of PET/CT Images of Immune Related Side Effects in Metastatic Melanoma Patients
- ClinicalTrials.gov ID
- NCT06207747
- Acronym / sponsor ID
- KME RS 0120-256/2020-14
- Keywords
- PET/CT, melanoma, immunotherapy, side-effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 17 Jan 2024 (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.
New cancer treatment with immune-checkpoint inhibitors (ICIs) has changed the way patients with melanoma and a variety of other cancers are being treated. Many pivotal trials that showed efficacy and safety of ICIs were performed in malignant melanoma. ICI can cause a different type of toxicity, called immune-related adverse events (irAEs). Though the exact pathophysiology is not completely understood, it is believed that irAEs are provoked by immune upregulation and inflammation. However, they can be serious, life-threatening, and warrant hospital admission as well. Dangerous irAEs include myocarditis, myositis, and pneumonitis, among others. Due to the novel mechanism of action, unpredictable nature, and wide usage of this type of treatment in the future, there is urgent need for better control of these potentially dangerous side effects. Early recognition and treatment of irAEs are of great importance in successful management.
Positron emission tomography-computed tomography (PET/CT) with [18F]2fluoro-2-deoxy-D-glucose (18F-FDG) is a sensitive, non-invasive, and widely used method for diagnosis and evaluation of treatment efficacy of malignant melanoma. The combination of 18F-FDG-PET and CT allows for assessment of both functional and morphological status of the lesions, and so facilitates better clinical decisions and patient care during treatment. It is also a very sensitive method for recognising inflammation, that can be a signal of irAEs.
Quantitative analysis is a rapidly evolving field of PET/CT image analysis. It includes both radiomics and artificial intelligence. Some studies have reported that quantitative analysis could predict efficacy of different cancer treatments. Quantitative image analysis in cancer response assessment is a rapidly expanding field, with the ultimate goal of clinical translation. However, in the specific instance of irAE diagnosis, it is not yet clear what role quantitative analysis of PET/CT scans can play.
The hypothesis is that quantitative analysis of PET/CT images provides more information on possible irAE, thus helping to treat these side effects more quickly and successfully.
Detailed description
New cancer treatment with immune-checkpoint inhibitors (ICIs) has changed the way patients with melanoma and a variety of other cancers are being treated. Based on many positive randomised controlled trials in metastatic and neo-/adjuvant setting, ICI agents targeting programmed death-1 (PD-1), programmed death ligand-1 (PD-L1) and cytotoxic T-lymphocyte antigen-4 (CTLA-4) have become invaluable in the treatment of different carcinomas. Many pivotal trials that showed efficacy and safety of ICIs were performed in malignant melanoma.
ICI can cause a different type of toxicity, called immune-related adverse events (irAEs), that can occur in any organ of the body. Though the exact pathophysiology is not completely understood, it is believed that irAEs are provoked by immune upregulation and inflammation. In general, they are less frequent compared to chemotherapy toxicities and usually low grade and manageable. However, they can be serious, life-threatening, and warrant hospital admission as well. Dangerous irAEs include myocarditis, myositis, and pneumonitis, among others. Due to the novel mechanism of action, unpredictable nature, and wide usage of this type of treatment in the future, there is urgent need for better control of these potentially dangerous side effects. Early recognition and treatment of irAEs are of great importance in successful management.
Positron emission tomography-computed tomography (PET/CT) with [18F]2fluoro-2-deoxy-D-glucose (18F-FDG) is a sensitive, non-invasive, and widely used method for diagnosis and evaluation of treatment efficacy of malignant melanoma. The combination of 18F-FDG-PET and CT allows for assessment of both functional and morphological status of the lesions, and so facilitates better clinical decisions and patient care during treatment. It is also a very sensitive method for recognising inflammation, that can be a signal of irAEs.
Quantitative analysis is a rapidly evolving field of PET/CT image analysis. It includes both radiomics and artificial intelligence. Quantitative analyses of medical images provide insight into hidden information about the image, which is usually not fully assessed by a nuclear medicine specialist (for example, information on the spatial heterogeneity of the tumour). Some studies have reported that quantitative analysis could predict efficacy of different cancer treatments. Quantitative image analysis in cancer response assessment is a rapidly expanding field, with the ultimate goal of clinical translation. However, in the specific instance of irAE diagnosis, it is not yet clear what role quantitative analysis of PET/CT scans can play.
The hypothesis is that quantitative analysis of PET/CT images provides more information on possible irAE, thus helping to treat these side effects more quickly and successfully. The association of quantitative PET/CT analysis with patient survival and the predictive value of an early-time point PET/CT scan in response to ICIs will be prospectively examined. The positive impact or irAE of autoimmune thyroiditis on the outcome of ICIs treatment will be also will be also evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will prospectively collect data from metastatic or stage III.D unresectable melanoma patients treated with ICIs and followed regularly with 18F-FDG PET/CT scans. Recruitment is expected to last 18 months. Predictive sample size is 100 melanoma patients. Timing of PET/CT scans: * Baseline PET/CT less than 4 weeks before first ICI infusion * Follow-up: 4 weeks (+/- 5 days) after first infusion, 16 weeks (+/- 7 days) after first infusion, then after every 16 weeks (+/- 7 days) or before in case of PD suspicion .
| Arm | Type | Receives |
|---|---|---|
| This study will prospectively collect data from metastatic or stage III.D unresectable melanoma pts | Experimental | Diagnostic Test: additional PET/CT at 4 weeks, analysing using quantative analysisTiming of PET/CT scans: * Baseline PET/CT less than 4 weeks before first ICI infusion * Follow-up: 4 weeks (+/- 5 days) after first infusion, 16 weeks (+/- 7 days) after first infusion, then after every 16 weeks (+/- 7 days) or before in case of PD suspicion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - Older than 18 years old
- Cyto- or histologically proven melanoma
- Stage III.D unresectable/ stage IV melanoma (AJCC classification, 8th edition, 2018)
- Asymptomatic brain metastases
- Three measurable metastatic lesions
Key exclusion criteria (4 listed)
- Symptomatic brain metastases
- PS WHO \> 2 (ECOG criteria)
- Contraindications for ICI treatment
- Other malignant diseases (not included: BCC, SCC, in situ carcinoma of cervix, other cured malignant diseases without relapse more than three years)
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 |
|---|---|---|
| additional PET/CT at 4 weeks, analysing using quantative analysisPatient with metastatic melanoma will be monitored with additional PET/CT at 4 weeks, analysing using quantative analysis will be done. | Diagnostic test | This study will prospectively collect data from metastatic or stage III.D unresectable melanoma pts |
Primary outcome
predictive value of PET/CT for detecting irAE
Time frame: two years
PET/CT will be performed regularly in metastatic melanoma patients treated with ICIs. Imaging will be analysed for detection of irAE, using in-depth radiological (nuclear) and quantitative (radiomic and artificial intelligence) analysis of affected organs. SUV percentiles of 18F-FDG uptake in the affected organs will be used for prediction of irAE.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Results publication: PubMed 34958422Hribernik N, Huff DT, Studen A, Zevnik K, Klanecek Z, Emamekhoo H, Skalic K, Jeraj R, Rebersek M. Quantitative imaging biomarkers of immune-related adverse events in immune-checkpoint blockade-treated metastatic melanoma patients: a pilot study. Eur J Nucl Med Mol Imaging. 2022 May;49(6):1857-1869. doi: 10.1007/s00259-021-05650-3. Epub 2021 Dec 27.
- Results publication: PubMed 34534974Huff DT, Ferjancic P, Namias M, Emamekhoo H, Perlman SB, Jeraj R. Image intensity histograms as imaging biomarkers: application to immune-related colitis. Biomed Phys Eng Express. 2021 Sep 30;7(6):10.1088/2057-1976/ac27c3. doi: 10.1088/2057-1976/ac27c3.
- 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.
Nežka Hribernik, M.D. principal investigator
Institute of Oncology Ljubljana, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional PET/CT at 4 weeks, analysing using quantative analysis in people with Melanoma and PET CT, 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 9 inclusion and 4 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 Jan 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?
Results are not available in the source record.
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?
predictive value of PET/CT for detecting irAE (time frame: two years). 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 NCT06207747, which also lists 2 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 Jan 2024.