NCT06207747

Quantitative Analysis of PET/CT Images of Immune Related Side Effects in Metastatic Melanoma Patients

Status unknown NA Last updated 17 January 2024

What this trial tests

NA trial testing additional PET/CT at 4 weeks, analysing using quantative analysis in Melanoma in 70 participants. Status unknown.

Timeline

1 September 2020

Primary endpoint
1 September 2023

10 September 2025

Quick facts

Lead sponsor	Institute of Oncology Ljubljana
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	70
Start date	1 September 2020
Primary completion	1 September 2023
Estimated completion	10 September 2025
Sites	1 location across Slovenia

Drugs / interventions tested

• additional PET/CT at 4 weeks, analysing using quantative analysis

Conditions studied

• Melanoma — all drugs for Melanoma →
• PET CT — all drugs for PET CT →

Sponsor

Institute of Oncology Ljubljana

Who can join

18 and older, any sex, with Melanoma or PET CT. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Role of quantitative imaging biomarkers in an early FDG-PET/CT for detection of immune-related adverse events in melanoma patients: a prospective study.
   Hribernik N, Strasek K, Huff DT, Studen A, et al · · 2024 · cited 2× · PMID 39287171 · DOI 10.2478/raon-2024-0045
2. Early-time-point <sup>18</sup>F-FDG-PET/CT and other prognostic biomarkers of survival in metastatic melanoma patients receiving immunotherapy.
   Hribernik N, Strasek K, Studen A, Zevnik K, et al · · 2025 · cited 1× · PMID 40014787 · DOI 10.2478/raon-2025-0014