Of 18F MEL050 Using PET/CT in Metastatic Melanoma

Metastatic Melanoma Clinical Trial

— MEL050  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01620749
• Other study ID #: 10/11
• Status: Active, not recruiting
• Phase: Phase 0
• First received: May 27, 2012
• Last updated: June 14, 2012
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2012
• Source: Cooperative Research Centre for Biomedical Imaging Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Radiation:
• 18F MEL050
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Cooperative Research Centre for Biomedical Imaging Development

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration.		Up to 28 days following 18F MEL050 administration (+/- 7 days)	Yes
Secondary	Percentage of injected 18F MEL050 dose in organs of interest.		10, 30, 60 and 120 minutes post 18F MEL050 administration	No
Secondary	Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.		60, 120 and 180 minutes post 18F MEL050 administration.	No
Secondary	Absorbed organ doses and whole body dose expressed as milliSv/200MBq administered dose.		10, 30, 60 and 120 minutes post 18F MEL050 administration	No