Clinical trial NCT02753569: Imaging NSCLC Treatment Response to Immunotherapy
Official title: Imaging NSCLC Treatment Response to Immunotherapy: Relating Inflammatory Activity on 18FDG PET to Tumour Specific Measures From DW-MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Magnetic Resonance Imaging
PET/CT
non-small cell lung cancer
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Royal Marsden NHS Foundation Trust
First posted: 2016-04-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes patients with NSCLC requiring palliative radiotherapy to the chest and for which no curative therapy exists.

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).

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.

Eligibility criteria: Inclusion Criteria:

* Recruited to PEAR: Phase 1 dose escalation of palliative radiotherapy with anti-PD1 antibody pembrolizumab in thoracic tumours Study

Exclusion Criteria:

* MRI incompatible metal implants
* Claustrophobia

Primary outcomes:
measure: Changes in DW-MRI derived ADC
timeFrame: Duration of Study - 2 year
measure: Changes in FDG PET/CT SUV
timeFrame: Duration of Study - 2 year
Secondary outcomes:
measure: Assess for differences in tumour volume using DW-MRI
timeFrame: Duration of Study - 2 year
measure: Assess for differences in tumour volume using 18FDG PET-CT
timeFrame: Duration of Study - 2 year
measure: Assess correlation between DW-MRI derived ADC and FDG PET/CT SUV
timeFrame: Duration of Study - 2 year
measure: Ability to predict progression free time and overall survival using DW-MRI ADC
timeFrame: Duration of Study - 2 year
measure: Ability to predict progression free time and overall survival using 18FDG SUV
timeFrame: Duration of Study - 2 year
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
References: