CompletedPhase 1ACTRN12612000775819

Investigating computed tomography ventilation as a functional imaging modality for lung cancer radiotherapy

Investigating computed tomography ventilation as a functional imaging modality for lung cancer radiotherapy in minimising radiation toxicity


Sponsor

University of Sydney

Enrollment

30 participants

Start Date

Aug 2, 2013

Study Type

Interventional

Conditions

Summary

This study looks at whether we can obtain information about lung function (showing us areas of lung that work well and areas that do not) from a type of computed tomography scan (CT scan) known as four dimension computed tomography scan (4D-CT scan). Unlike other types of CT scans, 4D-CT scans have the potential to provide lung function information as well as the usual anatomical information. It is hoped that we can then include this lung function information in the planning of radiotherapy treatment to reduce the chances of irradiating the functioning lung areas. This has the potential to minimise side-effects. 4D-CT scans are mainly used for early stage lung cancer patients where it provides highly accurate anatomical information, however, we are testing its use in providing additional information, lung function information, for all stages of lung cancer. If this study shows that 4D-CT scans can provide accurate lung function information, it will be used for the treatment planning of all stages of lung cancer which will allow better treatment delivery and hopefully better treatment outcomes. Who is it for? You may be eligible for this study if you are 18 and over and have been diagnosed with lung cancer and scheduled or not scheduled for treatment with radiotherapy. Further inclusion details for this trial can be found in the Inclusion Criteria section of this form. Trial details This is a 30 lung cancer patient clinical imaging study in assessing the accuracy of a new type of imaging data from computed tomography (CT) known as CT ventilation imaging. Patients will undergo CT scans, data from which will be used to create a ventilation image which will be compared to their ventilation image acquired from a nuclear medicine scan, considered to be the 'gold standard'. If CT ventilation imaging is found to be physiologically accurate, its great advantage lies in its easy implementation in radiotherapy planning to minimise radiation induced lung toxicity.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • This study is specifically aimed at lung cancer patients. Patients will fall into two groups, the majority of study patients will fall into the RT group (i.e, patients that are to be treated with radiotherapy) and a small number of patients will fall into the Non-RT group (i.e., patients that are not going to receive RT treatment and therefore will most probably be receiving chemotherapy).
  • RT Group: Stage I - IV patients treated with any type of RT
  • Non-RT group: Stage IIIB, IV (patients greater than or equal to 65 years old)
  • The ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria6

  • No pregnant women
  • children or young people <18 yrs
  • Curative intent patients for radiotherapy (other than SBRT treated)
  • Curative intent non-radiotherapy patients
  • No decisionally challenged individuals
  • People highly dependent on medical care

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Interventions

This is a validation study of utilising respiratory correlated computed tomography (CT) imaging (e.g, four dimensional CT) in obtaining the distribution of lung ventilation. The CT ventilation imaging

This is a validation study of utilising respiratory correlated computed tomography (CT) imaging (e.g, four dimensional CT) in obtaining the distribution of lung ventilation. The CT ventilation imaging will be validated with the gold standard in ventilation imaging, nuclear medicine ventilation imaging. The study participants will undergo (1) a CT imaging session where a four dimensional CT, a static end-inspiration breath hold CT and an end-expiration breath hold CT will be acquired and (2) a nuclear medicine imaging session where a PET-Galligas (alternative will be SPECT-Technegas) ventilation scan will be acquired. The CT ventilation images will then be used to create a functional based radiotherapy treatment plan. A standard anatomical based treatment plan will also be created which the functional based treatment plan will be compared to. We will estimate the difference in dose to the functional lungs (toxicity) between the standard of care anatomical based treatment plan used in radiotherapy planning and the study's functional based treatment plans. Neither of these plans will be used in the any of the study participants' treatments. Summary of imaging scans to be collected per study participant: Two static breath hold CT scans one collected after inhalation and the other after exhalation, One four-dimensional-CT (4D-CT) scan, One Nuclear Medicine ventilation scan (PET-Galligas or SPECT-Technegas). All CT scans will be obtained on the same day in one session on a dual modality PET/CT machine taking approximately 1.5 hour in total to complete. These scans will be collected only once in the study. The static breath hold CT scans will require the patient to hold their breath for 20 seconds during the scan acquisition. Each of the static breath hold CT scans will take less than 1 minute to complete. The 4D-CT scan will take approximately 3 minutes to complete. The nuclear medicine scan will take approximately 15 minutes to complete. In all the scans outlined above the participant will be asked to lie on their back with their arms above their head for the duration the scans. All the scans will be acquired with the use of a respiratory regulator system called the Audiovisual Biofeedback system. The Audiovisual Biofeedback system requires the participant to wear electronic goggles which will display their breathing pattern in the shape of a wave and they will be guided to maintain regular breathing by following the wave pattern during the image acquisitions. The total dose received from all scans in study will be approximately 50 - 70 mSv. The study will be accrue 30 patients over the period of 3 years. This study is specifically aimed at lung cancer patients. As this is not a treatment based study and the data is collected in the treatment phase, the study is open to non-RT treated lung cancer patients, chemotherapy patients. Patients will fall into two groups, the majority of study patients will fall into the RT group (i.e., patients that are to be treated with RT) and a small number of patients will fall into the Non-RT group (i.e., patients treated with chemotherapy). RT Group: Stage I - IV Non-RT Group: Stage IIIB, IV (patients greater than or equal to 65 years old)


Locations(1)

NSW, Australia

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ACTRN12612000775819