NCT04007068

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

Completed Last updated 18 October 2024

What this trial tests

trial testing FDG PET/CT in Non-small Cell Lung Cancer in 30 participants. Completed in 31 July 2019.

Timeline

1 January 2017

Primary endpoint
30 March 2019

31 July 2019

Quick facts

Lead sponsor	Institute of Oncology Ljubljana
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	1 January 2017
Primary completion	30 March 2019
Estimated completion	31 July 2019
Sites	1 location across Slovenia

Drugs / interventions tested

• FDG PET/CT

Conditions studied

• Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →

Sponsor

Institute of Oncology Ljubljana

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

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

1. [18F]FDG PET immunotherapy radiomics signature (iRADIOMICS) predicts response of non-small-cell lung cancer patients treated with pembrolizumab.
   Valentinuzzi D, Vrankar M, Boc N, Ahac V, et al · · 2020 · cited 51× · PMID 32726293 · DOI 10.2478/raon-2020-0042
2. The Role of Radiomics in the Era of Immune Checkpoint Inhibitors: A New Protagonist in the Jungle of Response Criteria.
   Castello A, Castellani M, Florimonte L, Urso L, et al · · 2022 · cited 20× · PMID 35330068 · DOI 10.3390/jcm11061740
3. Radiomics-guided checkpoint inhibitor immunotherapy for precision medicine in cancer: A review for clinicians.
   Zhou H, Luo Q, Wu W, Li N, et al · · 2023 · cited 6× · PMID 36936913 · DOI 10.3389/fimmu.2023.1088874