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Trial registered on ANZCTR


Registration number
ACTRN12613000061730
Ethics application status
Approved
Date submitted
15/01/2013
Date registered
16/01/2013
Date last updated
18/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective feasibility study of Gallium-68 ventilation and perfusion PET/CT during and after radiotherapy in patients with non-small cell lung cancer

Scientific title
A prospective feasibility study of Gallium-68 ventilation and perfusion PET/CT during and after radiotherapy in patients with non-small cell lung cancer

Secondary ID [1] 281700 0
Nil
Universal Trial Number (UTN)
U1111-1138-4421
Trial acronym
GALLIPET-VQRT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small cell lung cancer 287988 0
Condition category
Condition code
Cancer 288372 288372 0 0
Lung - Non small cell

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study aims to investigate radiation-related changes in ventilation and perfusion with 68Ga ventilation-perfusion PET/CT, a novel, high-resolution imaging modality.
A Gallium PET scan will be performed before radiotherapy treatment, midway through treatment, 3 months after treatment and 12 months after treatment.
A standard PET scan, similar to the one initially used to diagnose the extent of the cancer will be performed 3 months after radiotherapy treatment.
Lung spirometry tests (lung function tests) and 6 minute walk tests will be performed part of this study. In addition to the lung spirometry tests that are performed routinely before and after radiotherapy, lung spirometry will be performed midway through treatment. Walk tests will be performed before treatment, mid-way through treatment and every 3 months after treatment for up to 1 year.
In an additional translational sub-study, we propose to assess radiation induced DNA damage outside of radiation fields. These out-of-field effects may be related to systemic effects of radiation, which include nausea and fatigue and also may relate to the risk of secondary malignancy. As part of this study, patients will 4x9mL of blood taken at 5 timepoints during the trial for analysis of DNA damage.
Intervention code [1] 286236 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288544 0
Gallium PET/CT regional pulmonary perfusion
Timepoint [1] 288544 0
baseline, week 4 (mid treatment), month 3 (post treatment) and 12 month (post-treatment).
Secondary outcome [1] 300432 0
1. PFT measurements (FVC, FEV1, FEV1/FVC,DLCO), sum of Gallium PET/CT regional ventilation and perfusion
Timepoint [1] 300432 0
baseline, week 4 (mid treatment), month 3 (post treatment) and 12 months (post-treatment).
Secondary outcome [2] 300433 0
2. Quality of PET/CT co-registration
Timepoint [2] 300433 0
baseline, week 4 (mid treatment), month 3 (post treatment) and 12 months (post-treatment).
Secondary outcome [3] 300434 0
3.Radiotherapy dose, lung volume exposed, perfusion change as demonstrated on Gallium PET/CT from baseline to post-treatment (month 3).
Timepoint [3] 300434 0
baseline and 3 months post treatment
Secondary outcome [4] 300435 0
4.Lung ventilation, perfusion and density mismatches, PFT measurements (FVC, FEV1, FEV1/FVC,DLCO)
Timepoint [4] 300435 0
baseline, week 4 (mid treatment) and month 3 (post treatment).
Secondary outcome [5] 300666 0
Biomarker Substudy - In an additional translational sub-study, we propose to assess radiation induced DNA damage within blood. As part of this study, patients will have 4x9mL of blood taken at 5 timepoints during the trial for analysis of DNA damage.
Timepoint [5] 300666 0
baseline, 1 hour after 1st fraction, 1 hour before 2nd fraction, 4 weeks into radiotherapy, and 3 months post radiotherapy completion

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years.
Written informed consent has been provided.
FDG-PET scan performed for cancer staging.
Patients receiving curative intent radiotherapy for non-small cell lung cancer.
Minimum dose of radiotherapy prescribed is 60Gy with or without chemotherapy
ECOG performance status 0-2 inclusive
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participant is not able to tolerate supine position on PET/CT bed for the duration of the PET/CT acquisitions, is not cooperative, or needs continuous nursing (e.g. patient from Intensive Care Unit).
Pregnancy
Breast-feeding

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The data analysis of this feasibility study will be qualitative and quantitative.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6767 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 6137 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 286563 0
Self funded/Unfunded
Name [1] 286563 0
Address [1] 286563 0
Country [1] 286563 0
Australia
Funding source category [2] 290293 0
Government body
Name [2] 290293 0
Cancer Australia PDCCRS
Address [2] 290293 0
Australia's Head Office
Postal address: Locked Bag 3, STRAWBERRY HILLS NSW 2012

Country [2] 290293 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan St
Melbourne
Vic 3000
Country
Australia
Secondary sponsor category [1] 285348 0
None
Name [1] 285348 0
Address [1] 285348 0
Country [1] 285348 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288566 0
Peter MacCallum Cancer Centre HREC
Ethics committee address [1] 288566 0
305 Grattan St
Melbourne
Vic 3000
Ethics committee country [1] 288566 0
Australia
Date submitted for ethics approval [1] 288566 0
30/06/2011
Approval date [1] 288566 0
25/08/2011
Ethics approval number [1] 288566 0
11/64

Summary
Brief summary
This study aims to investigate radiation-related changes in the lungs using a novel, high-resolution imaging modality, in patients with non-small cell lung cancer.
Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are receiving curative intent radiotherapy for non-small cell lung cancer with or without chemotherapy. You should also have had a FDG-PET scan performed for staging of your cancer.
Study details: All participants in this study will undergo a Gallium PET scan before radiotherapy treatment, midway through treatment, 3 months after treatment and 12 months after treatment. They will also receive a standard PET scan (similar to the one initially used to diagnose the extent of the cancer) after 3 months after radiotherapy treatment. In addition, lung function tests and 6 minute walk tests will be performed before treatment, mid-way throughout treatment and every 3 months after treatment for up to 12 months. These assessments will enable us to evaluate changes in lung function. By documenting these changes, we aim to better understand the fundamental effects of radiation on pulmonary (lung) physiology, better predict for radiation toxicity, and in the future reduce radiation toxicity by avoiding irradiation of functionally critical segments of lung. In an additional sub-study we will collect blood samples at 5 different timepoints from before treatment to 3 months after radiation treatment, in order to assess radiation induced DNA damage outside of radiation fields.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36702 0
Dr Shankar Siva
Address 36702 0
Department of Radiation Oncology & Cancer Imaging Peter MacCallum Cancer
305 Grattan St
Melbourne 3000
Country 36702 0
Australia
Phone 36702 0
+61 3 85595000
Fax 36702 0
+61 3 8559 7719
Email 36702 0
shankar.siva@petermac.org
Contact person for public queries
Name 36703 0
Dr Shankar Siva
Address 36703 0
Department of Radiation Oncology & Cancer Imaging Peter MacCallum Cancer
305 Grattan St
Melbourne 3000
Country 36703 0
Australia
Phone 36703 0
+61 3 85595000
Fax 36703 0
+61 3 8559 7719
Email 36703 0
shankar.siva@petermac.org
Contact person for scientific queries
Name 36704 0
Dr Shankar Siva
Address 36704 0
Department of Radiation Oncology & Cancer Imaging Peter MacCallum Cancer
305 Grattan St
Melbourne 3000
Country 36704 0
Australia
Phone 36704 0
+61 3 85595000
Fax 36704 0
+61 3 8559 7719
Email 36704 0
shankar.siva@petermac.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary