Clinical trial · Interventional
Quantitative Analysis of PET/CT Images of Immune Related Side Effects in Metastatic Melanoma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| PET CT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| additional PET/CT at 4 weeks, analysing using quantative analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- This study will prospectively collect data from metastatic or stage III.D unresectable melanoma pts
- description
- 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
- interventionNames
- Diagnostic Test: additional PET/CT at 4 weeks, analysing using quantative analysis
Primary outcomes (1)
- measure
- predictive value of PET/CT for detecting irAE
- timeFrame
- two years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \- 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) * PS WHO 0-2 (ECOG criteria) * FDG-PET within four weeks of treatment initiation * Written consent form Exclusion Criteria: * 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)
References
Publications (2)
- RESULTHribernik 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. PMID 34958422
- RESULTHuff 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. PMID 34534974