Trials / Completed
CompletedNCT02753569
Imaging NSCLC Treatment Response to Immunotherapy
Imaging NSCLC Treatment Response to Immunotherapy: Relating Inflammatory Activity on 18FDG PET to Tumour Specific Measures From DW-MRI
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (actual)
- Sponsor
- Institute of Cancer Research, United Kingdom · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
30 patients, recruited from within the PEAR Study (Phase 1 dose escalation of palliative radiotherapy with anti-PD1 antibody pembrolizumab in thoracic tumours) will be scanned both before and after receiving immunotherapy for NSCLC. Immunotherapy induced changes in tumour ADC on DW-MRI (a surrogate of apoptotic tumour cell death) will be compared with changes in near contemporaneous, anatomically co-registered 18FDG PET-CT SUV (a non-specific marker for GLUT expression and hence metabolic activity in both tumour and tumour infiltrating lymphocytes). For treatment response, an increase in ADC (reflecting apoptosis within the tumour) is expected, while 18FDG uptake is expected to decrease compared with baseline tumour uptake. In the presence of significant inflammatory cell recruitment, the investigators hypothesise a similar increase in ADC on DW-MRI but without associated reduction in 18FDG PET-CT SUV. Thus the relationship between the ADC change on DW-MRI and the 18FDG change should distinguish between response and non-response in the presence of inflammation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Imaging - DW-MRI | |
| RADIATION | FDG PET-CT |
Timeline
- Start date
- 2016-05-31
- Primary completion
- 2020-05-14
- Completion
- 2020-05-14
- First posted
- 2016-04-28
- Last updated
- 2021-02-01
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02753569. Inclusion in this directory is not an endorsement.