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RecruitingNCT04676828ASPECTUpdated Feb 24, 2026

Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

An interventional study of Single-photon-emission CT scan in Lung Cancer, Radiation-Induced Disorder and Radiation Pneumonitis, sponsored by University of Aarhus. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2021; still recruiting 4 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

In this project, a novel method of safe radiotherapy delivery shall be tested for patients with lung cancer in a clinical setting. Functional avoidance radiotherapy is a new method that protect highly functional lung tissue from radiation, while delivering high dose radiotherapy to the lung tumour. Radiotherapy is usually based on a CT scan that does not account for functional variations in the lungs. Therefore, I hypothesize that using functional distribution in the lungs and avoiding irradiation of highly functional lung will improve treatment outcome for individual patients with lung cancer.

The objective of my project is to determine if functional image guided radiotherapy (functional avoidance radiotherapy) improves toxicity outcomes for patients with lung cancer undergoing curative chemo-radiotherapy in a prospective clinical trial.

To reach this objective, the impact of functional avoidance radiotherapy on pulmonary toxicity measured by the incidence and severity of radiation-induced lung disease shall be assessed. Additionally, loco-regional control, time to progression, overall survival, quality of life and radiation-induced molecular response in patients treated with functional avoidance radiotherapy shall be assessed and compared to patients receiving standard treatment.

02

Conditions studied

  • 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
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 90 is above the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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 before patient registration.

Exclusion criteria

Exclusion Criteria:

  • concurrent immunotherapy
  • previous radiotherapy to the thorax
  • other uncontrolled ; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    SPECT functional avoidance treatment

    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

  • No intervention
    Standard treatment

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

Interventions

  • Diagnostic testSingle-photon-emission CT scan

    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

06

What researchers measure

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.

    Time frame: Measured serially from 1 to 12 months after treatment completion

Secondary outcomes

  1. Quality of life

    Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires

    Time frame: Measured serially from 1 to 12 months after treatment completion

  2. Patient reported lung symptoms

    Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire

    Time frame: Measured serially from 1 to 12 months after treatment completion

  3. Progression-free survival

    time from randomization to disease progression at any site or death

    Time frame: at 12 months

  4. Overall survival

    time from randomization to death of any cause or last date known alive

    Time frame: at 12 months

  5. Loco-regional control rate

    freedom from local disease progression

    Time frame: at 12 months

07

Study locations

2 of 2 sites recruiting
  • 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
    • Azza Khalil, MD, PhD · Contactazza.khalil@auh.rm.dk · 004578465000
    • Line Sparvath · Contactlinspa@rm.dk · 004578465000
    • Katherina Farr, MD, PhD · Principal investigator
    • Azza Khalil, MD, PhD · Sub investigator
08

References and documents

Publications

  • 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. PubMed 34418994 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04676828
Collaborators
Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia, Aarhus University Hospital, South Eastern Sydney Local Health District, The University of New South Wales, Northern NSW Local Health District, NSW Australia
Responsible party
Katherina Farr, MD, PhD (Specialist in Clinical Oncology, Aarhus University Hospital) — Principal investigator
First posted
Dec 21, 2020
Start date
Dec 1, 2021
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Feb 24, 2026

Study contacts

Katherina Farr, MD PhD FRACP
Contact
Katherina.Farr@health.nsw.gov.au
+61 412695410

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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