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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 0
18 Years
N/A
Open (Enrolling)
Both
Metastatic Melanoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration.

Outcome Time Frame:

Up to 28 days following 18F MEL050 administration (+/- 7 days)

Safety Issue:

Yes

Principal Investigator

Grant McArthur

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

10/11

NCT ID:

NCT01620749

Start Date:

June 2010

Completion Date:

December 2012

Related Keywords:

  • Metastatic Melanoma
  • melanoma metastatic diagnosis
  • Melanoma

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