Lung CancerASPECTNCT04676828
Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer
A study testing Single-photon-emission CT scan in people with Lung Cancer and Radiation-Induced Disorder, run by University of Aarhus at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Radiation-Induced Disorder, Radiation Pneumonitis
- What is being tested?
- Single-photon-emission CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Dec 2021to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- concurrent immunotherapy
- previous radiotherapy to the thorax
- other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals
Sydney, New South Wales, 2145
Eric Hau, MBBS PhD FRANZCR, +61 432207880, Eric.Hau@health.nsw.gov.au
Eric Hau, MBBS PhD
Denmark1 site, 1 recruiting
- Recruiting
Department of Oncology, Aarhus University Hospital
Aarhus, DK-8000
Azza Khalil, MD, PhD, 004578465000, azza.khalil@auh.rm.dk
Line Sparvath, 004578465000, linspa@rm.dk
About this study
Official title: Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial
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.
- Conditions
- Lung Cancer, Radiation-Induced Disorder, Radiation Pneumonitis, Pulmonary Disease, Lung Function Decreased
- Being tested
- Single-photon-emission CT scan
- Keywords
- radiation-induced lung toxicity, functional avoidance methodology, radiation therapy of lung cancer
- Medical subject headings
- Lung Neoplasms, Abnormalities, Radiation-Induced, Radiation Pneumonitis, Lung Diseases, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-photon-emission CT scanDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Single-photon-emission CT scan |
| Standard treatment | No intervention | CT-based radiation therapy given over 5- 6.5 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured serially from 1 to 12 months after treatment completion
Secondary outcomes (5)
Quality of life
Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires
Measured: Measured serially from 1 to 12 months after treatment completion
Patient reported lung symptoms
Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire
Measured: Measured serially from 1 to 12 months after treatment completion
Progression-free survival
time from randomization to disease progression at any site or death
Measured: at 12 months
Overall survival
time from randomization to death of any cause or last date known alive
Measured: at 12 months
Loco-regional control rate
freedom from local disease progression
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Dec 2021
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blinded phase 2
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Katherina Farr, MD, PhD, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676828
- Sponsor's protocol ID
- KFE-1930
- Acronym
- ASPECT
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2020
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04676828
- Acronym / sponsor ID
- ASPECT / KFE-1930
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- 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
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blinded phase 2
| Arm | Type | Receives |
|---|---|---|
| SPECT functional avoidance treatment | Experimental | Diagnostic Test: Single-photon-emission CT scanSPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation. |
| Standard treatment | No intervention | –CT-based radiation therapy given over 5- 6.5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- concurrent immunotherapy
- previous radiotherapy to the thorax
- other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-photon-emission CT scanSPECT/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 | Diagnostic test | SPECT functional avoidance treatment |
Primary outcome
Radiation-induced lung toxicity
Time frame: Measured serially from 1 to 12 months after treatment completion
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.
5 secondary outcomes
Quality of life
Time frame: Measured serially from 1 to 12 months after treatment completion
Patient reported lung symptoms
Time frame: Measured serially from 1 to 12 months after treatment completion
Progression-free survival
Time frame: at 12 months
Overall survival
Time frame: at 12 months
Loco-regional control rate
Time frame: at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Derived from this study: PubMed 34418994Khalil 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-photon-emission CT scan in people with Lung Cancer and Radiation-Induced Disorder, run by University of Aarhus at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherina Farr, MD PhD FRACP (+61 412695410, Katherina.Farr@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation-induced lung toxicity (time frame: Measured serially from 1 to 12 months after treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04676828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.