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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.
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.
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.
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.
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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F MEL050 for finding sites of melanoma.
Trial website
https://clinicaltrials.gov/study/NCT01620749
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01620749