FDG PET/CT Radiomics Analyses of Lung Cancer Patients Treated With Immunotherapy

NCT04007068 | Completed

• 1 other identifier: KME 117/02/17
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose iRADIOMICS, a highly innovative and potentially clinical practice changing tool, which will allow for better management of patients undergoing immunotherapy. iRADIOMICS is based on in-depth interrogation of the molecular imaging (FDG PET/CT) data, extracting "invisible" information based on physical description of the imaging information. Based on the promising preliminary results of our pilot study, the investigators hypothesise that radiomics analyses of FDG PET/CT scans of patients treated with immunotherapy (iRADIOMICS) can better predict response to immunotherapy compared to the current standards (iRC). iRADIOMICS will be assessed in a prospective clinical study, involving 30 patients with metastatic non-small-cell lung cancer, treated with anti-programmed death-1 (anti-PD1) antibodies. Patients will undergo FDG PET/CT before the administration of anti-PD-1, at 1 month and 4 months after the administration. Afterwards, the patients will be imaged with FDG PET/CT every 6 months. Additionally, the patients will undergo diagnostic CT scan every 3 months to allow for comparison to the current standard (irRC).

Conditions

Non-small Cell Lung Cancer

Keywords

RADIOMICS ANALYSIS

Outcome Measures

Primary Outcomes (1)

• Correlation of iRADIOMICS with survival

  To evaluate whether iRADIOMICS predicts response to immunotherapy better than irRC.

  1.1.2017 - 31.12.2020

Interventions

FDG PET/CT DIAGNOSTIC_TEST

FDG PET/CT baseline, month 1, month 4, month 10, than every 6 months

Eligibility Criteria

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

Study Population

Cytologically or histologically confirmed NSCLC patients with PD-L1 TPS ≥1% in stage IVa, IVb or recurrent NSCLC (classification IASLC, 7th edition, 2009) that are candidates for immunotherapy.

You may qualify if:

• Age ≥ 18 years;
• Cytologically or histologically confirmed NSCLC with PD-L1 TPS ≥1% (confirmed by a validated test);
• Stage IVa, IVb or recurrent NSCLC (classification IASLC, 7th edition, 2009);
• Up to 10 metastases in multiple organ systems, or more than 10 metastases in more than two organ systems;
• No signs of active and/or untreated brain metastases;
• At least three measurable lesions;
• Progression after the first or second-line systemic therapy;
• WHO performance status 0-2 (ECOG criteria);
• Following the decision of multidisciplinary board that the patient is a candidate for treatment with pembrolizumab;
• FDG PET/CT performed up to 4 weeks prior to treatment;
• Performed diagnostic CT scans (thorax and abdomen) up to 4 weeks prior to treatment;
• Signed and dated written informed consent.

You may not qualify if:

• Symptomatic and/or untreated brain metastases;
• History of other malignancies, except for the following: adequately treated basal or squamous cell carcinoma of the skin, curatively treated in situ carcinoma of the uterine cervix, other curatively treated solid tumour with no evidence of disease for ≥ 3 years;
• All contraindications for treatment with pembrolizumab.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead
• University of Ljubljana: collaborator

Study Sites (1)

Institut of oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: January 1, 2017
• Primary Completion: March 30, 2019
• Study Completion: July 31, 2019
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)