Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
12 participants
INTERVENTIONAL
2010-06-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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MEL050
18F MEL050
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.
Interventions
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18F MEL050
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.
Eligibility Criteria
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Inclusion Criteria
* Male and female patients with histologically confirmed melanoma
* At least one site of metastatic disease, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care
* Age \>/= 18 years
* Life expectancy \>/=3 months
* ECOG performance score of 0-2
Exclusion Criteria
* Systemic anti-melanoma therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F MEL050 PET/CT scan
* Patients whose clinical care may be compromised because of the delay resulting from performance of the 18F MEL050 PET/CT scan
* Patients whose only metastatic lesion is in the Central Nervous System
* Patients with urinary incontinence or patients who cannot comfortably hold their urine for more than 90 minutes
* Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
* Patients unwilling or unable to comply with protocol and patients with a history of non compliance or inability to grant informed consent.
18 Years
ALL
No
Sponsors
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Cooperative Research Centre for Biomedical Imaging Development
OTHER
Responsible Party
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Principal Investigators
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Grant McArthur
Role: PRINCIPAL_INVESTIGATOR
Peter MacCallum Cancer Centre, Australia
Locations
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Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
Countries
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Other Identifiers
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10/11
Identifier Type: -
Identifier Source: org_study_id
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