TY - JOUR
T1 - Single-arm prospective interventional study assessing feasibility of using gallium-68 ventilation and perfusion PET/CT to avoid functional lung in patients with stage III non-small cell lung cancer
AU - Bucknell, Nicholas
AU - Hardcastle, Nicholas
AU - Jackson, Price
AU - Hofman, Michael
AU - Callahan, Jason
AU - Eu, Peter
AU - Iravani, Amir
AU - Lawrence, Rhonda
AU - Martin, Olga
AU - Bressel, Mathias
AU - Woon, Beverley
AU - Blyth, Benjamin
AU - MacManus, Michael
AU - Byrne, Keelan
AU - Steinfort, Daniel
AU - Kron, Tomas
AU - Hanna, Gerard
AU - Ball, David
AU - Siva, Shankar
N1 - Funding Information:
Contributors NWB, SS, MH, NH, JC, DB, TK, OM, BB, RL, MB, AI, BW, PE and DS contributed to the initial conception and design of the study. SS, GH, MH, JC and NWB were instrumental in securing funding and departmental support for the project. NWB led the development of the initial study protocol, which SS, NH, DB, TK, OM, BB, RL, MB, AI, BW, JC, PJ, MM, KB and DS reviewed and provided feedback on. NWB drafted the protocol manuscript and all other authors gave critical feedback. All authors read and approved the final version of the manuscript and agree to be accountable for all aspects of the work. Funding This work was supported by RANZCR grant number 2017/014, the Peter MacCallum Cancer Centre Foundation grant number 1709. NWB is the recipient of an Graduate Research Scholarship funded by the Australian Government. A Cancer Australia Priority-drive Collaborative CancerResearch Scheme Grant 2013, APP1060919, supported the development of V/Q PET/CT. This research was supported by the Cancer Trials Management Scheme Competitive Grants Programme, administered by Cancer Council Victoria. Competing interests None declared.
Publisher Copyright:
© 2020 Author(s) (or their employer(s)). Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2020/12/10
Y1 - 2020/12/10
N2 - Background In the curative-intent treatment of locally advanced lung cancer, significant morbidity and mortality can result from thoracic radiation therapy. Symptomatic radiation pneumonitis occurs in one in three patients and can lead to radiation-induced fibrosis. Local failure occurs in one in three patients due to the lungs being a dose-limiting organ, conventionally restricting tumour doses to around 60 Gy. Functional lung imaging using positron emission tomography (PET)/CT provides a geographic map of regional lung function and preclinical studies suggest this enables personalised lung radiotherapy. This map of lung function can be integrated into Volumetric Modulated Arc Therapy (VMAT) radiotherapy planning systems, enabling conformal avoidance of highly functioning regions of lung, thereby facilitating increased doses to tumour while reducing normal tissue doses. Methods and analysis This prospective interventional study will investigate the use of ventilation and perfusion PET/CT to identify highly functioning lung volumes and avoidance of these using VMAT planning. This single-arm trial will be conducted across two large public teaching hospitals in Australia. Twenty patients with stage III non-small cell lung cancer will be recruited. All patients enrolled will receive dose-escalated (69 Gy) functional avoidance radiation therapy. The primary endpoint is feasibility with this achieved if ≥15 out of 20 patients meet pre-defined feasibility criteria. Patients will be followed for 12 months post-treatment with serial imaging, biomarkers, toxicity assessment and quality of life assessment. Discussion Using advanced techniques such as VMAT functionally adapted radiation therapy may enable safe moderate dose escalation with an aim of improving local control and concurrently decreasing treatment related toxicity. If this technique is proven feasible, it will inform the design of a prospective randomised trial to assess the clinical benefits of functional lung avoidance radiation therapy. Ethics and dissemination This study was approved by the Peter MacCallum Human Research Ethics Committee. All participants will provide written informed consent. Results will be disseminated via publications. Trials registration number NCT03569072; Pre-results.
AB - Background In the curative-intent treatment of locally advanced lung cancer, significant morbidity and mortality can result from thoracic radiation therapy. Symptomatic radiation pneumonitis occurs in one in three patients and can lead to radiation-induced fibrosis. Local failure occurs in one in three patients due to the lungs being a dose-limiting organ, conventionally restricting tumour doses to around 60 Gy. Functional lung imaging using positron emission tomography (PET)/CT provides a geographic map of regional lung function and preclinical studies suggest this enables personalised lung radiotherapy. This map of lung function can be integrated into Volumetric Modulated Arc Therapy (VMAT) radiotherapy planning systems, enabling conformal avoidance of highly functioning regions of lung, thereby facilitating increased doses to tumour while reducing normal tissue doses. Methods and analysis This prospective interventional study will investigate the use of ventilation and perfusion PET/CT to identify highly functioning lung volumes and avoidance of these using VMAT planning. This single-arm trial will be conducted across two large public teaching hospitals in Australia. Twenty patients with stage III non-small cell lung cancer will be recruited. All patients enrolled will receive dose-escalated (69 Gy) functional avoidance radiation therapy. The primary endpoint is feasibility with this achieved if ≥15 out of 20 patients meet pre-defined feasibility criteria. Patients will be followed for 12 months post-treatment with serial imaging, biomarkers, toxicity assessment and quality of life assessment. Discussion Using advanced techniques such as VMAT functionally adapted radiation therapy may enable safe moderate dose escalation with an aim of improving local control and concurrently decreasing treatment related toxicity. If this technique is proven feasible, it will inform the design of a prospective randomised trial to assess the clinical benefits of functional lung avoidance radiation therapy. Ethics and dissemination This study was approved by the Peter MacCallum Human Research Ethics Committee. All participants will provide written informed consent. Results will be disseminated via publications. Trials registration number NCT03569072; Pre-results.
KW - nuclear radiology
KW - radiation oncology
KW - respiratory tract tumours
KW - toxicity
UR - http://www.scopus.com/inward/record.url?scp=85097891663&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-042465
DO - 10.1136/bmjopen-2020-042465
M3 - Article
C2 - 33303468
AN - SCOPUS:85097891663
VL - 10
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 12
M1 - e042465
ER -