Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

NCT04676828 | Recruiting DMC

• 1 other identifier: KFE-1930
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief Summary

Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)/CT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.

Conditions

Lung Cancer; Radiation-Induced Disorder; Radiation Pneumonitis; Pulmonary Disease; Lung Function Decreased

Keywords

radiation-induced lung toxicity; functional avoidance methodology; radiation therapy of lung cancer

Outcome Measures

Primary Outcomes (1)

• Radiation-induced lung toxicity

  crude rate of symptomatic radiation-induced lung toxicity of grade 2 and higher. According to the Common Toxicity Criteria for Adverse Events version 5.0 for radiation pneumonitis, dyspnea, cough, or any other radiation-induced respiratory, thoracic and mediastinal disorder.

  Measured serially from 1 to 12 months after treatment completion

Secondary Outcomes (5)

• Quality of life

  Measured serially from 1 to 12 months after treatment completion

• Patient reported lung symptoms

  Measured serially from 1 to 12 months after treatment completion

• Progression-free survival

  at 12 months

• Overall survival

  at 12 months

• Loco-regional control rate

  at 12 months

Study Arms (2)

SPECT functional avoidance treatment

EXPERIMENTAL

SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.

Diagnostic Test: Single-photon-emission CT scan

Standard treatment

NO INTERVENTION

CT-based radiation therapy given over 5- 6.5 weeks.

Interventions

Single-photon-emission CT scan DIAGNOSTIC_TEST

SPECT/CT scan is an established functional modality used in the diagnosis and monitoring of lung disease. SPECT/CT scan images pulmonary circulation, where perfused areas equate with normal functional lung

SPECT functional avoidance treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically verified lung cancer (small-cell and non-small cell lung cancer)
• referred for radiotherapy with curative intent
• radiation dose of 60-66 Gy given in 2-Gy fractions, other dose levels and fractionation schedules accepted, as per site standard
• concurrent chemotherapy is accepted
• patients with oligometastatic disease are allowed, where metastasis have been ablated with surgery or radiotherapy
• receiving (chemo)-radiotherapy to the thoracic disease with curative intent
• adults over 18, that have given oral and written informed consent before patient registration.

You may not qualify if:

• concurrent immunotherapy
• previous radiotherapy to the thorax
• other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• The University of New South Wales: collaborator
• Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia: collaborator
• South Eastern Sydney Local Health District: collaborator
• Northern NSW Local Health District, NSW Australia: collaborator

Study Sites (2)

Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals

Sydney, New South Wales, 2145, Australia

RECRUITING

Department of Oncology, Aarhus University Hospital

Aarhus, DK-8000, Denmark

RECRUITING

Related Publications (1)

• Khalil AA, Hau E, Gebski V, Grau C, Gee H, Nyeng TB, West K, Kramer S, Farlow D, Knap M, Moller DS, Hoffmann L, Farr KP. Personal innovative approach in radiation therapy of lung cancer- functional lung avoidance SPECT-guided (ASPECT) radiation therapy: a study protocol for phase II randomised double-blind clinical trial. BMC Cancer. 2021 Aug 21;21(1):940. doi: 10.1186/s12885-021-08663-1.

  PMID: 34418994 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Abnormalities, Radiation-Induced; Radiation Pneumonitis; Lung Diseases; Respiratory Insufficiency

Interventions

Tomography, Emission-Computed, Single-Photon

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Radiation Injuries; Wounds and Injuries; Lung Diseases, Interstitial; Lung Injury; Respiration Disorders

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Central Study Contacts

Katherina Farr, MD PhD FRACP

CONTACT

+61 412695410; Katherina.Farr@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers and outcome assessors are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Clinical Oncology

Model Details: Randomized double-blinded phase 2

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DK (1)