FINE: Imaging fibrosis in lung cancer and relating findings to outcomes of treatment

Not Applicable

• Conditions: ung cancer; Cancer

• Registration Number: ISRCTN13047154
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-15
• Last Update Posted: 19 December 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cohort 1 (measured at the time of resection): <br>1. The degree of fibrosis on the 68Ga-FAPI scan measured by SUV (standardised uptake volume) over a ROI (region of interest) <br>2. Markers of fibroblast activation from the excised tissue (measured by multiparametric flow cytometry analysis), including FAP, CD34, aSMA, podoplanin)<br><br>Cohort 2:<br>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<br>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

Name	Time	Method
Cohort 1: Laboratory markers including T-cell phenotypes within the tumour measured using biopsy at the time of resection<br>Cohort 2: Progression free survival and mortality measured using patient records up to 1 year