Primary Objectives- To investigate the impact of dose reduction of 18F-FDG on image quality of PET-MRII in patients with melanoma. Secondary Objectives- To determine the maximum reduction of radiation dose for 18F-FDG PET-MRI as compared to…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Image analysis for primary endpoint, i.e image quality:
- Image quality will be scored on a 4-point scale according to Halpern et al
(34) ranging from 0 to 3: 0 (non-diagnostic), 1 (poor), 2 (moderate) and 3
(good).
- Lesion detectability between reconstructions will be evaluated by counting
the number of 18F-FDG positive lesions per body region (head/neck, thorax,
abdomen, soft tissue of extremities and skeleton) according to different
reconstructions. The lesions will be categorized as follows: 0 lesions (0), 1
lesion (1), 2 lesions (2), 3-5 lesions (3), 6-10 lesions (4) and >10 lesions
(5).
Secondary outcome
Image analysis for secondary endpoints, i.e. diagnostic performance:
Diagnostic performances of the 4 index tests (18F-FDG PET/MRI, 18F-FDG
PET-CT, contrast enhanced CT and TB MRI) will be measured on a per-patient
level. Sensitivity, specificity, PPV and NPV will be calculated based on the
per-patient outcomes (0 or >=1 metastasis).
Number of metastases will be counted per-patient and will be
categorized as follows: 0 metastasis (0), 1-5 metastases (1), and > 5
metastases (2).
Background summary
Melanoma is an aggressive form of skin cancer and is responsible for most skin
related deaths (1). In Europe, the incidence rates between 1995 and 2012
increased significantly for both men and women. In particular, the Netherlands
showed a remarkable increase in incidence rate. As a result, an increase in
mortality has been reported . However, in the past decade, considerable
progress has been made in the treatment of metastatic melanoma .
New therapies such as immunotherapy (immune checkpoint inhibitors) and targeted
therapy (BRAF/MEK-inhibitors) have shown considerable survival benefits (1).
Immune checkpoint inhibitors can induce durable tumor responses up to 10 years
or even longer. As a result, patients with advanced melanoma are subjected to a
long follow-up period (10 years) after discontinuation of treatment.
For early detection of recurrent or progressive disease, a contrast enhanced
computed tomography (CT) is usually performed every 3 months and this interval
can be increased every year thereafter. Depending on local institutional
guidelines, contrast enhanced CT is combined with positron emission tomography
(PET) using fluor-18 fluorodeoxyglucose positron emission tomography (18F-FDG
PET). However, these imaging techniques are associated with radiation exposure.
The average radiation exposure caused by one contrast enhanced CT-scan of the
thorax and abdomen is 8.4 millisievert (mSv). In addition, the average
radiation exposure caused by 18F-FDG (3.3 mSv) for PET with a low-dose CT (3.1
mSv) is 6.4 mSv.
Study objective
Primary Objectives
- To investigate the impact of dose reduction of 18F-FDG on image quality of
PET-MRII in patients with melanoma.
Secondary Objectives
- To determine the maximum reduction of radiation dose for 18F-FDG PET-MRI as
compared to contrast enhanced CT and 18F-FDG PET-CT.
- To determine the diagnostic performance of PET-MRI using a reduced dose of
18F-FDG in patients with advanced melanoma
- To compare the diagnostic performance of PET-MRI using a reduced dose of
18F-FDG with 18F-FDG PET-CT, contrast enhanced CT and TB MRI.
Study design
This is a prospective, explorative study in patients with melanoma.
Study burden and risks
Patients with melanoma who are referred for routine 18F-FDG PET/CT will be
asked to undergo an additional PET-MRI with administration of gadolinium
contrast agent on the same day. After injection of 18F-FDG and image
acquisition using PET-CT, patients will undergo PET-MRI. For PET-MRI, there
will be no additional radiation exposure, as 18F-FDG will be administered once
(prior to PET-CT). Gadolinium contrast agent will be dosed according to local
guidelines (one bolus of 7.5 cc gadobutrol 1,0 mmol/ml (Gadovist*)).
Additional PET-CT scan will require the patients to lay still in the PET-MRI
scanner for approximately 60 minutes which may cause discomfort for the
patients.
Gadolinium may cause contrast agent related reaction(s). However, an up-to-date
protocol has been prepared by our institute on how to handle if contrast agent
related reaction(s) appear.
Considering the potential benefit of this study for future follow-up of
patients with melanoma, the additional imaging with PET-MRI is considered
justified.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Histopathological proven melanoma for which 18F-FDG PET-CT is indicated. For
example, patients in follow-up or under treatment can be included.
- Referral for 18F-FDG PET-CT at Erasmus MC
- Signed informed consent
- Age >= 18 years
- Willing to undergo additional PET-MRI
Exclusion criteria
- Contra-indications to undergo MRI:
o Pacemaker, mechanic heart valve, blood vessel prosthetic, stent or coil
o Metal in eyes (splinters, from surgery), ears (hearing aid) or on the body
where it cannot be removed (insulin pump, piercings etc.)
o Dental prosthesis with magnetic system
o Claustrophobia
- Pregnancy or breastfeeding
- Allergy to contrast agent containing gadolinium
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76024.078.21 |