Status:
UNKNOWN
Quantitative Analysis of PET/CT Images of Immune Related Side Effects in Metastatic Melanoma Patients
Lead Sponsor:
Institute of Oncology Ljubljana
Conditions:
Melanoma
PET CT
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- \- 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
- 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)
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06207747
Start Date
September 1 2020
End Date
September 10 2025
Last Update
January 17 2024
Active Locations (1)
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1
Institute of Oncology Ljubljana
Ljubljana, Slovenia