CancerNCT02753569
Imaging NSCLC Treatment Response to Immunotherapy
An observational study of Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Imaging - DW-MRI and FDG PET-CT
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2016to 14 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients with NSCLC requiring palliative radiotherapy to the chest and for which no curative therapy exists.
Who may be able to join
- Recruited to PEAR: Phase 1 dose escalation of palliative radiotherapy with anti-PD1 antibody pembrolizumab in thoracic tumours Study
Who cannot join
- MRI incompatible metal implants
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: Imaging NSCLC Treatment Response to Immunotherapy: Relating Inflammatory Activity on 18FDG PET to Tumour Specific Measures From DW-MRI
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).
Read the 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
- Cancer
- Being tested
- Imaging - DW-MRI, FDG PET-CT
- Keywords
- Magnetic Resonance Imaging, PET/CT, non-small cell lung cancer
- Medical subject headings
- Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging - DW-MRIOther
FDG PET-CTRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Duration of Study - 2 year
Secondary outcomes (5)
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.
Measured: Duration of Study - 2 year
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.
Measured: Duration of Study - 2 year
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.
Measured: Duration of Study - 2 year
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.
Measured: Duration of Study - 2 year
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.
Measured: Duration of Study - 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start31 May 2016
- Primary completion14 May 2020
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Royal Marsden NHS Foundation Trust
- Responsible party
- Principal investigator, Nandita deSouza, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753569
- Sponsor's protocol ID
- CCR4364
- Status last verified
- Jan 2021
- First submitted
- 20 Apr 2016
- Last updated
- 1 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging NSCLC Treatment Response to Immunotherapy: Relating Inflammatory Activity on 18FDG PET to Tumour Specific Measures From DW-MRI
- ClinicalTrials.gov ID
- NCT02753569
- Acronym / sponsor ID
- CCR4364
- Conditions
- Cancer
- Keywords
- Magnetic Resonance Imaging, PET/CT, non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Royal Marsden NHS Foundation Trust
- Study start
- 31 May 2016 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients with NSCLC requiring palliative radiotherapy to the chest and for which no curative therapy exists.
Key inclusion criteria (1 listed)
- Recruited to PEAR: Phase 1 dose escalation of palliative radiotherapy with anti-PD1 antibody pembrolizumab in thoracic tumours Study
Key exclusion criteria (2 listed)
- MRI incompatible metal implants
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging - DW-MRI | Other | – |
| FDG PET-CT | Radiation | – |
Primary outcome
Changes in DW-MRI derived ADC
Time frame: Duration of Study - 2 year
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.
Changes in FDG PET/CT SUV
Time frame: Duration of Study - 2 year
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.
5 secondary outcomes
Assess for differences in tumour volume using DW-MRI
Time frame: Duration of Study - 2 year
Assess for differences in tumour volume using 18FDG PET-CT
Time frame: Duration of Study - 2 year
Assess correlation between DW-MRI derived ADC and FDG PET/CT SUV
Time frame: Duration of Study - 2 year
Ability to predict progression free time and overall survival using DW-MRI ADC
Time frame: Duration of Study - 2 year
Ability to predict progression free time and overall survival using 18FDG SUV
Time frame: Duration of Study - 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in DW-MRI derived ADC (time frame: Duration of Study - 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.