melanoma skin cancer
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Exposure group: • The patient has a diagnosis of melanoma stage III. • The patient is scheduled to be treated with (neo-)adjuvant ICI immunotherapy. • The patient is 18 years or older. • The patient has given written informed consent. Control group: • The patient has a diagnosis of melanoma stage I or II. • The patient will not be treated with ICI immunotherapy. • The patient is 18 years or older. • The patient has given written informed consent. • If possible: the patient uses cholesterol-lowering drugs in the case that statins are initiated after baseline CCTA scan for a patient in the exposure group to whom the patient can be matched
Exclusion criteria
Exclusion criteria: The patient is unable to give informed consent. The patient suffers from severe psychiatric disorder. The patient has a history of cardiovascular disease. The patient has a contra-indication for a PET or CT-scan. If female and fertile: signs and symptoms of pregnancy or a positive pregnancy test / breast-feeding, (severe) claustrophobia. Low dose benzodiazepines are allowed. The patients uses cholesterol-lowering-drugs before baseline scans (only exposure group). The patients actively uses or is scheduled to use > 10 mg prednisolone per day and/or treatment with an equivalent dose of other systemic corticosteroids. The patient has uncontrolled diabetes/elevated blood glucose levels (>11.1 mmol/L). The use of short-acting insulins within 4 hours of the PET scan is not allowed The patient is unable to understand, or unlikely to comply with, the study requirements. The patient does not wish to be informed of incidental findings (e.g. cancer metastasis or other disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the study are: - The absolute and relative change in 18F-FDG uptake in prespecified arterial segments defined by maximum target-to-background-ratio (TBRmax) between baseline, 6 months (exposure group only) and 18 months (PET-CT). - The absolute and relative change of total plaque volume in respectively mm3 and % in the coronary arteries between baseline and 18 months in the exposure group (CCTA). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints will be: - Incidence of major adverse cardiac events at follow up: Acute coronary syndrome (ACS), Ischemic stroke, Cardiac death, Peripheral arterial disease requiring interventional treatment - The change plaque composition and in the coronary arteries determined by Hounsfield units (HU) between baseline and after 18 months in the exposure group. - The change between baseline and after 18 months in the levels of biochemical markers of inflammation and atherosclerosis (e.g. GDF 15, PCT, OPN, Copeptin, ET-1, MPO, Ang-2, Relaxin-1, NT-proBNP, Troponine-T) | — |
Countries
Netherlands
Contacts
Public ContactN Laâchir
Leids Universitair Medisch Centrum
Outcome results
None listed