Imaging NSCLC Treatment Response to Immunotherapy
1 other identifier
observational
10
1 country
1
Brief Summary
This feasibility study will aim to assess the potential for functional imaging biomarkers (18FDG PET-CT and DW-MRI) to differentiate immunotherapy induced inflammation, indicative of response from non-response in patients with stage IV non-small cell lung cancer (NSCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedStudy Start
First participant enrolled
May 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2020
CompletedFebruary 1, 2021
January 1, 2021
4 years
April 20, 2016
January 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in DW-MRI derived ADC
Describing changes in DW-MRI derived ADC will provide data that may be used to differentiate immune mediated response from non-response in a future study of treatment responses following immunotherapy.
Duration of Study - 2 year
Changes in FDG PET/CT SUV
Describing changes in 18FDG-PET SUV will provide data that may be used to differentiate immune mediated response from non-response in a future study of treatment responses following immunotherapy.
Duration of Study - 2 year
Secondary Outcomes (5)
Assess for differences in tumour volume using DW-MRI
Duration of Study - 2 year
Assess for differences in tumour volume using 18FDG PET-CT
Duration of Study - 2 year
Assess correlation between DW-MRI derived ADC and FDG PET/CT SUV
Duration of Study - 2 year
Ability to predict progression free time and overall survival using DW-MRI ADC
Duration of Study - 2 year
Ability to predict progression free time and overall survival using 18FDG SUV
Duration of Study - 2 year
Interventions
Eligibility Criteria
The study population includes patients with NSCLC requiring palliative radiotherapy to the chest and for which no curative therapy exists.
You may qualify if:
- Recruited to PEAR: Phase 1 dose escalation of palliative radiotherapy with anti-PD1 antibody pembrolizumab in thoracic tumours Study
You may not qualify if:
- MRI incompatible metal implants
- Claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Translational Imaging
Study Record Dates
First Submitted
April 20, 2016
First Posted
April 28, 2016
Study Start
May 31, 2016
Primary Completion
May 14, 2020
Study Completion
May 14, 2020
Last Updated
February 1, 2021
Record last verified: 2021-01