Clinical trial · Interventional
Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer
Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial
NCT04676828CI-TRIAL-00103954ASPECTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Function Decreased | — | UNRESOLVED | — |
| Pulmonary Disease | — | UNRESOLVED | — |
| Radiation-Induced Disorder | — | UNRESOLVED | — |
| Radiation Pneumonitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single-photon-emission CT scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SPECT functional avoidance treatment
- description
- SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.
- interventionNames
- Diagnostic Test: Single-photon-emission CT scan
- type
- NO_INTERVENTION
- label
- Standard treatment
- description
- CT-based radiation therapy given over 5- 6.5 weeks.
Primary outcomes (1)
- measure
- Radiation-induced lung toxicity
- timeFrame
- Measured serially from 1 to 12 months after treatment completion
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * concurrent immunotherapy * previous radiotherapy to the thorax * other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
References
Publications (1)
- DERIVEDKhalil 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