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

NCT06207747 | Unknown

• 1 other identifier: KME RS 0120-256/2020-14
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 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

Melanoma; PET CT

Keywords

PET/CT; melanoma; immunotherapy; side-effects

Outcome Measures

Primary Outcomes (1)

• 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.

  two years

Study Arms (1)

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

Diagnostic Test: additional PET/CT at 4 weeks, analysing using quantative analysis

Interventions

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

Patient with metastatic melanoma will be monitored with additional PET/CT at 4 weeks, analysing using quantative analysis will be done.

This study will prospectively collect data from metastatic or stage III.D unresectable melanoma pts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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
• st, 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia

Location

Related Publications (2)

• 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.

  PMID: 34958422 RESULT

• Huff 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 RESULT

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nežka Hribernik, M.D.

  Institute of Oncology Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 .

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 17, 2024
• Study Start: September 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 10, 2025
• Last Updated: January 17, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)