FINE: Imaging fibrosis in lung cancer and relating findings to outcomes of treatment
| ISRCTN | ISRCTN13047154 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13047154 |
| IRAS number | 299962 |
| Secondary identifying numbers | AC21071, IRAS 299962, CPMS 51140 |
- Submission date
- 17/11/2021
- Registration date
- 15/02/2022
- Last edited
- 06/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Lung cancer is the leading cause of cancer related death worldwide and most patients have progressive disease or relapse despite therapy and new therapies that target the immune system. The tumour microenvironment (TME) is a collection of several different cell types, including a cell called fibroblasts. The fibroblasts within lung cancer express a protein called FAP and this protein can now be imaged using scans called PET scans. Therefore, using imaging (with a specialised PET scan) could allow us to determine which patients have a FAP active tumour, and which do not, which in turn could inform us as to which patients may need additional treatments targeting the TME/fibroblasts to help therapy be more effective. This study looks to lay the foundations for the use of PET imaging of FAP in NSCLC by using small numbers of patients who have been diagnosed with lung cancer and perform a FAP-PET scan at a single time point, following which the patients all receive their usual standard care. We will recruit patients who are planned to have surgical excision of the tumour, as well as patients who are due to have drug based anti-cancer therapy (including immune targeting regimes). This study looks to help us understand if the FAP-PET signal corresponds to i) the amount of FAP active fibroblasts in a tumour and ii) if this can potentially indicate subsequent failure of treatment, prior to subsequent larger trials.
Who can participate?
Participants aged over 50 years old with confirmed lung cancer who are either undergoing planned surgical resection (cohort 1) or planned systemic oncological treatment (cohort 2)
What does the study involve?
The study involves eligible participants undergoing a research PET scan. They may also be asked to provide a small blood sample, up to 20mls. If the participant is on the surgical pathway (cohort 1), we will also obtain a sample of lung tissue following surgery. Participants clinical records will be followed-up for up to 1 year
What are the potential benefits and risks of participating?
The PET scan is an extra scan in addition to routine care, therefore there is small increase in the amount of radiation exposure.
There is a potential risk of an allergic reaction to the radiotracer which is very rare (serious allergic reactions occur in approximately 1 in 10,000 patients) and we have clear procedures for managing such reactions. There is also a small risk of bleeding, bruising and infection from the cannula insertion but we will follow a sterile procedure.
Where is the study run from?
Royal Infirmary of Edinburgh (UK)
When is the study starting and how long is it expected to run for?
April 2021 to December 2023
Who is funding the study?
Cancer Research UK
Who is the main contact?
Dr Ahsan Akram, ahsan.akram@ed.ac.uk
Contact information
Scientific
University of Edinburgh
Centre For Inflammation Research
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
 ORCID ID |
0000-0003-4605-1682 |
|---|---|
| Phone | +44 (0)131 2429180 |
| ahsan.akram@ed.ac.uk |
Public
University of Edinburgh
Centre For Inflammation Research
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
| Phone | +44 (0)131 2429180 |
|---|---|
| k.hamilton@ed.ac.uk |
Study information
| Study design | Single-site observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 40688 PIS 24Aug2021 v2.pdf |
| Scientific title | Imaging Fibroblast Activation Protein (FAP) in non-small cell lung cancer using PET scan and correlation with outcomes of usual therapy. |
| Study acronym | FINE |
| Study objectives | Can fibrosis activity (measured by FAP specific PET-CT) be correlated with the response to therapy in non-small cell lung cancer? |
| Ethics approval(s) | Approved 27/08/2021, West of Scotland REC 5 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, PAISLEY, PA2 7DE, UK; +44 (0)141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: 21/WS/0094 |
| Health condition(s) or problem(s) studied | Lung cancer |
| Intervention | Eligible participants from both cohorts, will undergo a research scan (PET-CT scan using the FAP radiotracer) and it is possible the eligibility assessment/consent occur on the same day as the scan. Blood will be drawn at consent and at the time of the PET-CT scan if on separate days. Cohort 1 will undergo resection of their tumour and once the specimen has been resected areas of tumour and non-cancerous lung will be dissected by a trained pathologist of ex-vivo assays undertaken in the University of Edinburgh. The surgical resection forms part of the routine care. The additional specimens taken by the research team form part of the study. No further study interventions will be undertaken with cohort 1, though in an observational manner the cohort will have their notes reviewed for up to 1 year for outcome metrics. Cohort 2 will include patients who are referred to medical oncology for systemic anti-cancer therapy. Following the PET-CT, no further study interventions will be undertaken with cohort 2, though in an observational manner the cohort will have their notes reviewed for up to 1 year for outcome metrics, including routine care CT scans that may be undertaken. |
| Intervention type | Other |
| Primary outcome measure | Cohort 1 (measured at the time of resection): 1. The degree of fibrosis on the 68Ga-FAPI scan measured by SUV (standardised uptake volume) over a ROI (region of interest) 2. Markers of fibroblast activation from the excised tissue (measured by multiparametric flow cytometry analysis), including FAP, CD34, aSMA, podoplanin) Cohort 2: 1. The degree of fibrosis on the 68Ga-FAPI scan measured by SUV (standardised uptake volume) over a ROI (region of interest) measured at the time of resection 2. Treatment response measured by visual inspection of CT scan using RECIST and iRECIST methods post treatment and on usual scans up to 1 year |
| Secondary outcome measures | Cohort 1: Laboratory markers including T-cell phenotypes within the tumour measured using biopsy at the time of resection Cohort 2: Progression free survival and mortality measured using patient records up to 1 year |
| Overall study start date | 16/04/2021 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | Cohort 1: 5 patients, cohort 2: 10 patients |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. Capacity to provide informed consent 2. Confirmed lung cancer for which surgical resection is being planned (Cohort 1) 3. Confirmed lung cancer (cohort 2) planned for systemic oncological treatment 4. Treatment naïve patients ≥50 years 5. Thoracic CT scan taken within the previous 12 weeks 6. ECOG performance status 0-2 |
| Key exclusion criteria | 1. Inability or unwilling to give informed consent. 2. Unable to tolerate the supine position 3. Impaired renal function with eGFR of <30 mL/min/1.73m² 4. Severe or significant comorbidity that prevents systemic oncological therapy or performance status 3 or 4 5. Women who are pregnant or breastfeeding |
| Date of first enrolment | 19/11/2021 |
| Date of final enrolment | 10/10/2022 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Old Dalkeith Road
Edinburgh
EH16 4SA
United Kingdom
Sponsor information
University/education
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)1312423326 |
|---|---|
| resgov@accord.scot | |
| Website | https://www.accord.scot |
"ROR" |
https://ror.org/01nrxwf90 |
Hospital/treatment centre
University of Edinburgh
Centre For Inflammation Research
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)1312423325 |
|---|---|
| accord@nhslothian.scot.nhs.uk | |
| Website | https://www.accord.scot |
|
"ROR" |
https://ror.org/03q82t418 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 29/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this study will be published in peer reviewed journals and disseminated to clinical colleagues |
| IPD sharing plan | The datasets generated during and during the current study will be available upon request from the study team following completion of the study. (ahsan.akram@ed.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 24/08/2021 | 17/11/2021 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
06/12/2023: The intention to publish date was changed from 29/02/2024 to 29/06/2024.
04/09/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 01/09/2022 to 10/10/2022.
2. The overall study end date was changed from 01/09/2023 to 31/12/2023.
3. The intention to publish date was changed from 01/09/2023 to 29/02/2024.
4. Total final enrolment added.
02/03/2022: The intention to publish date has been changed from 01/03/2023 to 01/09/2023.
02/03/2022: Internal review.
01/03/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/03/2022 to 01/09/2022.
2. The overall trial end date was changed from 01/03/2023 to 01/09/2023.
17/11/2021: Trial's existence confirmed by West of Scotland Research Ethics Service.
