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A pilot study of two new imaging scans after high precision radiation therapy for patients with limited secondary spread of cancer to the lung.

A pilot study of Imaging in Stereotactic Ablative Frameless Radiosurgery for Oligometastatic Neoplasia to the lung.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000746730
Acronym
SAFRON
Enrollment
11
Registered
2013-07-04
Start date
2010-11-04
Completion date
2012-02-09
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Stereotactic body radiotherapy (SBRT) is an new form of cancer treatment involving highly precise radiotherapy. SBRT appears to be very effective in controlling cancer. After the treatment is given, however, with standard scans we have not been able to reliably assess how well the treatment worked. We propose to research SBRT with state-of-the-art scanning tools in patients with cancer spread to the lung. We aim to better understand how cancer responds to this therapy. This is the first step of the research, and is a small ‘pilot’ study. The ‘pilot’ is designed to assess whether the research can be completed. Who is it for? This trial is for patients who have cancer which has spread to the lung. We aim to enrol ten patients in total to participate in the research. These patients will be invited through Peter MacCallum at East Melbourne. Trial details: If you participate in this study you will have two different types of scans as well as a single stereotactic body radiotherapy session (SBRT). The two types of scans we are researching are called a four-dimensional positron emission tomography (4D-PET) scan and a computed tomography (CT) perfusion scan. Both scans are slow and recorded along with your breathing, which allows us to see how much your organs move as you breathe in and out. Each 4D-PET scan is broken down into many separate scans, each showing where your organs and the cancer are at a specific point of your breathing, for example, just as you start breathing in. For us to know whether you are breathing in or out, we will monitor your chest movement using breathing equipment. This will be done by either putting a belt around your chest or abdomen which senses your breathing, or a small lightweight reflective box on your chest and watch this using a special camera in the room. Both devices can tell us at which part of your breathing cycle each CT or PET image was taken, so we can make sets of images from each phase. Either device can be used during your scan, and this will depend on the particular machine on which you have your scan taken. The CT perfusion scan is similar to a standard CT scan, but is taken over a longer period of time with more contrast. This allows us to record the flow of contrast and blood flow into the cancer. Specifically, the research involves: 1. Before treatment, you will have a four-dimensional positron emission tomography (4D-PET) scan and a computed tomography (CT) perfusion scan, as a baseline. 2. After treatment, you will have another 4D-PET scan and a CT perfusion scan at day 14 and day 70. These will be compared with the first scans in order to assess how your cancer responded to the treatment. The stereotactic body radiotherapy (SBRT) treatment itself will routinely involve a third type of scan: a cone-beam CT. This scan is performed on the treatment machine, and is used to make the treatment more precise. Specifically, the stereotactic radiotherapy treatment involves as standard: 3. Prior to treatment whilst being set-up on the treatment machine, a cone-beam CT will be used to check the position of the cancer. This will be repeated immediately before the treatment and again mid-way through the treatment (a total of 3 cone-beam CTs). 4. A single high-precision, high-dose radiotherapy (SBRT) treatment directed against the cancer. Follow-up will involve a visit at approximately 2.5 to 3 months, and then at 6 months, 9 months, and 12 months from treatment. Participation in this study will involve no extra cost due to either having these scans or the treatment.

Interventions

If you participate in this study you will have two different types of scans as well as a single stereotactic body radiotherapy session (SBRT). The two types of scans we are researching are called a four-dimensional positron emission tomography (4D-PET) scan and a computed tomography (CT) perfusion scan. Both scans are slow and recorded along with your breathing, which allows us to see how much your organs move as you breathe in and out. Each 4D-PET scan is broken down into many separate scans,

If you participate in this study you will have two different types of scans as well as a single stereotactic body radiotherapy session (SBRT). The two types of scans we are researching are called a four-dimensional positron emission tomography (4D-PET) scan and a computed tomography (CT) perfusion scan. Both scans are slow and recorded along with your breathing, which allows us to see how much your organs move as you breathe in and out. Each 4D-PET scan is broken down into many separate scans, each showing where your organs and the cancer are at a specific point of your breathing, for example, just as you start breathing in. For us to know whether you are breathing in or out, we will monitor your chest movement using breathing equipment. This will be done by either putting a belt around your chest or abdomen which senses your breathing, or a small lightweight reflective box on your chest and watch this using a special camera in the room. Both devices can tell us at which part of your breathing cycle each CT or PET image was taken, so we can make sets of images from each phase. Either device can be used during your scan, and this will depend on the particular machine on which you have your scan taken. The CT perfusion scan is similar to a standard CT scan, but is taken over a longer period of time with more contrast. This allows us to record the flow of contrast and blood flow into the cancer. Specifically, the research involves: 1. Before treatment, you will have a four-dimensional positron emission tomography (4D-PET) scan and a computed tomography (CT) perfusion scan, as a baseline. 2. After treatment, you will have another 4D-PET scan and a CT perfusion scan at day 14 and day 70. These will be compared with the first scans in order to assess how your cancer responded to the treatment. Each scan will take approximately 30 minutes of time. The stereotactic body radiotherapy (SBRT) treatment itself will routinely involve a third type of scan: a cone-beam CT. This scan is performed on the treatment machine, and is used to make the treatment more precise. Specifically, the stereotactic radiotherapy treatment involves as standard: 3. Prior to treatment whilst being set-up on the treatment machine, a cone-beam CT will be used to check the position of the cancer. This will be repeated immediately before the treatment and again mid-way through the treatment (a total of 3 cone-beam CTs). 4. A single high-precision, high-dose radiotherapy (SBRT) treatment directed against the cancer. The treatment is a 26Gy single fraction. The treatment will take approximately 60 minutes. Follow-up will involve a visit at approximately 2.5 to 3 months, and then at 6 months, 9 months, and 12 months from treatment. Participation in this study will involve no extra cost due to either having these scans or the treatment.

Sponsors

Peter MacCallum Cancer Centre
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

One or two metastases within the lung parenchyma. Patients with primary cancers of epithelial, sarcomatoid or germ cell histologies who are treated with curative intent. Aged 18 years or older. ECOG performance of 0-2 inclusive. The tumour must have a peripheral location, defined as at least 1cm beyond the mediastinum and beyond the bifurcation of the lobar bronchi. Maximal tumour diameter < 5cm. No known extrathoracic disease prior to enrollment. Primary is controlled. Patient has provided written informed consent for participation in this trial prior to any protocol specific procedures. Patient must be medically inoperable, have technically high risk disease for surgery or refuse surgery.

Exclusion criteria

Previous high-dose thoracic radiotherapy. Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are not excluded (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotrophin releasing hormone receptor modulators). Any patient who is currently pregnant or breastfeeding.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026