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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01620749




Registration number
NCT01620749
Ethics application status
Date submitted
27/05/2012
Date registered
15/06/2012
Date last updated
15/06/2012

Titles & IDs
Public title
Of 18F MEL050 Using PET/CT in Metastatic Melanoma
Scientific title
A Phase 0 Exploratory Microdosing Study of 6-18fluoro-N-[2-(Diethylamino)Ethyl]Pyridine-3-carboxamide (18F MEL050) Using PET/CT in Patients With Metastatic Melanoma
Secondary ID [1] 0 0
10/11
Universal Trial Number (UTN)
Trial acronym
MEL050
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 18F MEL050

Experimental: MEL050 -


Treatment: Other: 18F MEL050
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration.
Assessment method [1] 0 0
Timepoint [1] 0 0
Up to 28 days following 18F MEL050 administration (+/- 7 days)
Secondary outcome [1] 0 0
Percentage of injected 18F MEL050 dose in organs of interest.
Assessment method [1] 0 0
Timepoint [1] 0 0
10, 30, 60 and 120 minutes post 18F MEL050 administration
Secondary outcome [2] 0 0
Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.
Assessment method [2] 0 0
Timepoint [2] 0 0
60, 120 and 180 minutes post 18F MEL050 administration.
Secondary outcome [3] 0 0
Absorbed organ doses and whole body dose expressed as milliSv/200MBq administered dose.
Assessment method [3] 0 0
Timepoint [3] 0 0
10, 30, 60 and 120 minutes post 18F MEL050 administration

Eligibility
Key inclusion criteria
* Written informed consent obtained prior to any protocol-specific procedures
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or breastfeeding females
* 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2012
Actual
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Cooperative Research Centre for Biomedical Imaging Development
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Grant McArthur
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01620749