Of 18F MEL050 Using PET/CT in Metastatic Melanoma (MEL050)

June 14, 2012 updated by: Cooperative Research Centre for Biomedical Imaging Development

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MEL050
Radiation: 18F MEL050
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration.
Time Frame: Up to 28 days following 18F MEL050 administration (+/- 7 days)
Up to 28 days following 18F MEL050 administration (+/- 7 days)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of injected 18F MEL050 dose in organs of interest.
Time Frame: 10, 30, 60 and 120 minutes post 18F MEL050 administration
10, 30, 60 and 120 minutes post 18F MEL050 administration
Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.
Time Frame: 60, 120 and 180 minutes post 18F MEL050 administration.
60, 120 and 180 minutes post 18F MEL050 administration.
Absorbed organ doses and whole body dose expressed as milliSv/200MBq administered dose.
Time Frame: 10, 30, 60 and 120 minutes post 18F MEL050 administration
10, 30, 60 and 120 minutes post 18F MEL050 administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cooperative Research Centre for Biomedical Imaging Development

Investigators

  • Principal Investigator: Grant McArthur, Peter MacCallum Cancer Centre, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

May 27, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (Estimate)

June 15, 2012

Study Record Updates

Last Update Posted (Estimate)

June 15, 2012

Last Update Submitted That Met QC Criteria

June 14, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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