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

NCT04007068 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-10-18

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

FDG PET/CT

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

Sponsors & Collaborators

  • University of Ljubljana

    collaborator OTHER
  • Institute of Oncology Ljubljana

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-03-30
Completion
2019-07-31

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04007068 on ClinicalTrials.gov