Additional value of 18F-FDG PET-MRI in patients with melanoma

Additional value of 18F-FDG PET-MRI in patients with melanoma - 18F-FDG PET-MRI bij melanoom

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50805

Enrollment

Registered

2021-11-29

Start date

2021-12-01

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

melanoma skin cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Netherlands

Outcome results