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Trial registered on ANZCTR


Trial ID
ACTRN12614000546651
Ethics application status
Approved
Date submitted
12/05/2014
Date registered
22/05/2014
Date last updated
22/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
In patients with locally spread melanoma, does staging with 18F-fluorodeoxyglucose positron emission tomography and brain magnetic resonance imaging change the initial treatment plan?
Scientific title
Does staging with 18F-FDG PET/CT and brain MRI alter the initial treatment proposal in melanoma patients with satellite or in-transit metastases as a first recurrence or at time of diagnosis? A prospective study.
Secondary ID [1] 284577 0
Nil
Universal Trial Number (UTN)
U1111-1156-7017
Trial acronym
The CHANGE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma - In transit / satellite metastasis 291866 0
Condition category
Condition code
Cancer 292218 292218 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Staging total body 18F-Fluorodeoxyglucose Positron Emission Tomography (18F-FDG PET/CT) and Magnetic Resonance Imaging of the brain (brain MRI) at time of diagnosis of any first in transit or satellite metastasis to routinely screen for any distant metastasis.
The duration of the 18F-FDG PET/CT procedure will approximately be 2 hours, of which the imaging itself will be 30-60 minutes. The duration of the brain MRI will be 30-45 minutes. If the first imaging does not show any suspected lesions and, after six months, there are no clinical signs of distant spread of melanoma, both imaging techniques will be repeated once.
Intervention code [1] 289354 0
Diagnosis / Prognosis
Intervention code [2] 289415 0
Early detection / Screening
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292087 0
Percentage of patients with change of disease management.
Timepoint [1] 292087 0
After completion of staging with whole body 18F-fluorodeoxyglucose PET/CT and brain MRI.
Secondary outcome [1] 308189 0
Change of AJCC stage.
Timepoint [1] 308189 0
After completion of staging with whole body 18F-fluorodeoxyglucose PET/CT and brain MRI.
Secondary outcome [2] 308346 0
18F-FDG PET/CT and brain MRI sensitivity and specificity.
Timepoint [2] 308346 0
After completion of staging with whole body 18F-fluorodeoxyglucose PET/CT and brain MRI.
Secondary outcome [3] 308347 0
Subgroup analysis on the effect of the number of in transit metastases or satellites on change of management
Timepoint [3] 308347 0
After completion of staging with whole body 18F-fluorodeoxyglucose PET/CT and brain MRI.

Eligibility
Key inclusion criteria
Patients with cutaneous melanoma and clinically or pathologically confirmed satellite or in-transit metastasis (N2c) without clinical evidence of metastases elsewhere (stage IIIB, C).
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical evidence of nodal or distant metastasis at time of enrolment.
Previous satellite or in-transit metastasis.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A feasibility estimate was conducted based on incidence in the previous five years at Melanoma Institute Australia. The eligible number of patients is estimated to be 85 annually: 27 patients with (micro) satellites, 13 with primary melanoma and in-transit metastasis and 45 with first in-transit recurrence.
A sample size calculation was conducted based on the assumption that a change in management in 10% of the study population is clinically relevant. A sample size of 34 from a population of 2000 achieves 90% power to detect a difference (P1-P0) of 0.1000 using a one-sided binomial test. The target significance level is 0.0500. The actual significance level achieved by this test is 0.0440.

Recruitment
Recruitment status
Recruiting
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)
NSW
Recruitment hospital [1] 2449 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 2478 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment postcode(s) [1] 8113 0
2050 - Camperdown
Recruitment postcode(s) [2] 8131 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 289210 0
Charities/Societies/Foundations
Name [1] 289210 0
The Friends of the Mater Foundation
Address [1] 289210 0
PO Box 958
North Sydney, 2059 NSW
Country [1] 289210 0
Australia
Funding source category [2] 289211 0
Charities/Societies/Foundations
Name [2] 289211 0
Groningen Melanoma and Sarcoma
Foundation.
Address [2] 289211 0
Ubbergseveldweg 144
6522 JR Nijmegen
Country [2] 289211 0
Netherlands
Funding source category [3] 289212 0
Charities/Societies/Foundations
Name [3] 289212 0
Stichting Vreedefonds
Address [3] 289212 0
Herengracht 537
1017 BV Amsterdam
Country [3] 289212 0
Netherlands
Primary sponsor type
Individual
Name
Prof. John Francis Thompson
Address
The Poche Centre
40 Rocklands Road
North Sydney 2060 NSW
Country
Australia
Secondary sponsor category [1] 287886 0
Individual
Name [1] 287886 0
Lodewijka H.J. Holtkamp, MD
Address [1] 287886 0
The Poche Centre
40 Rocklands Road
North Sydney 2060 NSW
Country [1] 287886 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290984 0
HREC RPAH zone
Ethics committee address [1] 290984 0
RESEARCH DEVELOPMENT OFFICE
ROYAL PRINCE ALFRED HOSPITAL
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 290984 0
Australia
Date submitted for ethics approval [1] 290984 0
27/11/2013
Approval date [1] 290984 0
12/03/2014
Ethics approval number [1] 290984 0
HREC/13/RPAH/586

Summary
Brief summary
This study aims to evaluate the influence of whole body 18F-FDG PET/CT and brain MRI on management of stage III melanoma patients with satellite or in-transit metastases as a first recurrence or at time of diagnosis.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have satellite or in-transit cutaneous melanoma metastases as a first recurrence or at time of diagnosis, in absence of clinical evidence of nodal and/or distant metastasis.

Study details
All participants in this study will undergo staging total body 18F-Fluorodeoxyglucose Positron Emission Tomography and Magnetic Resonance Imaging of the brain at time of diagnosis of any first in transit or satellite metastasis to routinely screen for any distant metastasis. A positron emission tomography (PET) scan is a non-invasive procedure that uses a small and safe amount of a radioactive substance to detect disease in your body. A computed tomography (CT or CAT) scan is also a non-invasive procedure and uses x-rays. Combined in a PET/CT scan this creates three-dimensional pictures of your body. A small amount of a radioactive material needs to be injected into a vein in your arm. The total duration of the procedure is usually 2 hours, the imaging itself usually 30-60 minutes. MRI (Magnetic Resonance Imaging) is a non-invasive procedure that uses a magnet and radiofrequency energy to produce detailed images of your body. An injection of contrast agent into a vein in the arm is required. The MRI examination usually lasts 30-45 minutes. MRI is not suitable for some participants with pacemakers or other metal implants. If the first scans do not show any suspective lesions and, after six months, there are no visible signs of distant spread of melanoma, both scans will be repeated once. We will determine the percentage of patients with change of disease management arising from these additional scans. Participants will be followed up at 6 months to determine the diagnostic accuracy of the scans and whether their disease stage has changed.
Trial website
Trial related presentations / publications
11/04/2014 - Presentation at Melanoma Institute Australia Multidisciplinary Team Meeting.
Public notes

Contacts
Principal investigator
Name 48270 0
Prof John Francis Thompson
Address 48270 0
The Poche Centre
40 Rocklands Road
North Sydney NSW 2060
Country 48270 0
Australia
Phone 48270 0
+612 9911 7366
Fax 48270 0
+61 2 9954 9290
Email 48270 0
john.thompson@melanoma.org.au
Contact person for public queries
Name 48271 0
Dr Lodewijka Holtkamp
Address 48271 0
The Poche Centre
40 Rocklands Road
North Sydney NSW 2060
Country 48271 0
Australia
Phone 48271 0
+ 614 1620 3938
Fax 48271 0
+61 2 9954 9290
Email 48271 0
wieke.holtkamp@melanoma.org.au
Contact person for scientific queries
Name 48272 0
Dr Lodewijka Holtkamp
Address 48272 0
The Poche Centre
40 Rocklands Road
North Sydney NSW 2060
Country 48272 0
Australia
Phone 48272 0
+ 614 1620 3938
Fax 48272 0
+61 2 9954 9290
Email 48272 0
wieke.holtkamp@melanoma.org.au