Imaging NSCLC Treatment Response to Immunotherapy

Cancer Clinical Trial

Official title:

Imaging NSCLC Treatment Response to Immunotherapy: Relating Inflammatory Activity on 18FDG PET to Tumour Specific Measures From DW-MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753569
• Other study ID #: CCR4364
• Status: Completed
• Start date: May 31, 2016
• Est. completion date: May 14, 2020

Study information

• Verified date: January 2021
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 14, 2020
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Imaging - DW-MRI

Radiation:
• FDG PET-CT

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom	National Institute for Health Research, United Kingdom, Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Assess for differences in tumour volume using DW-MRI	Assess for differences in tumor volume evaluated using DW-MRI. This will be used as a comparison against other modalities for assessing differences in tumour volume e.g. 18FDG PET-CT. CT is the current standard for radiotherapy target volumes in the chest and with the greater soft tissue delineation facilitated by MRI, comparison of the modalities is warranted.	Duration of Study - 2 year
Secondary	Assess for differences in tumour volume using 18FDG PET-CT	Assess for differences in tumor volume evaluated using 18FDG PET-CT. This will be used as a comparison against other modalities for assessing differences in tumour volume e.g. MRI. CT is the current standard for radiotherapy target volumes in the chest and with the greater soft tissue delineation facilitated by MRI, comparison of the modalities is warranted.	Duration of Study - 2 year
Secondary	Assess correlation between DW-MRI derived ADC and FDG PET/CT SUV	Assess the correlation between 18FDG PET Standardised Uptake Values and DW-MRI derived ADC values. Correlations between ADCmax and SUVmax; ADCmean and SUVmean; plus total lesion ADC and total lesion glycolysis will be explored. Recent reports of imaging biomarkers for defining radiotherapy 'dose painting' schedules have focussed on PET imaging and correlation of these parameters with DW-MRI is not yet established.	Duration of Study - 2 year
Secondary	Ability to predict progression free time and overall survival using DW-MRI ADC	Assess DW-MRI ADC, used alone or in combination with 18FDG SUV (before and after immunotherapy), for its ability to predict progression free and overall survivals following subsequent radiotherapy.	Duration of Study - 2 year
Secondary	Ability to predict progression free time and overall survival using 18FDG SUV	Assess 18FDG SUV, used alone or in combination with DW-MRI ADC (before and after immunotherapy), for their ability to predict progression free and overall survivals following subsequent radiotherapy.	Duration of Study - 2 year