Trial | NCT01620749  Report issue

Title

Of 18F MEL050 Using PET/CT in Metastatic Melanoma
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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    18f mel050 ...

  • Study Participants

    12
The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F MEL050 for finding sites of melanoma.
Study Started
Jun 30
2010
Primary Completion
Mar 31
2012
Study Completion
Dec 31
2012
Anticipated
Last Update
Jun 15
2012
Estimate

Radiation 18F MEL050

Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.

MEL050 Experimental

Criteria 

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.
No Results Posted