In patients with locally spread melanoma, does staging with 18F-fluorodeoxyglucose positron emission tomography and brain magnetic resonance imaging change the initial treatment plan?

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.

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000546651

Acronym

The CHANGE study

Enrollment

Registered

2014-05-22

Start date

2014-05-07

Completion date

2015-05-04

Last updated

2021-07-05

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

Conditions

None listed

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.

Interventions

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 a

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 99 Years

Healthy volunteers

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).

Exclusion criteria

Clinical evidence of nodal or distant metastasis at time of enrolment. Previous satellite or in-transit metastasis.

Outcome results