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

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ClinicalTrials.gov Identifier: NCT01620749
Recruitment Status : Unknown
Verified June 2012 by Cooperative Research Centre for Biomedical Imaging Development.
Recruitment status was:  Active, not recruiting
First Posted : June 15, 2012
Last Update Posted : June 15, 2012
Sponsor:
Information provided by (Responsible Party):
Cooperative Research Centre for Biomedical Imaging Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Radiation: 18F MEL050 Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : June 2010
Actual Primary Completion Date : March 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: MEL050 Radiation: 18F MEL050
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Percentage of injected 18F MEL050 dose in organs of interest. [ Time Frame: 10, 30, 60 and 120 minutes post 18F MEL050 administration ]
  2. Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration. [ Time Frame: 60, 120 and 180 minutes post 18F MEL050 administration. ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620749


Locations
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Cooperative Research Centre for Biomedical Imaging Development
Investigators
Principal Investigator: Grant McArthur Peter MacCallum Cancer Centre, Australia
More Information
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Responsible Party: Cooperative Research Centre for Biomedical Imaging Development
ClinicalTrials.gov Identifier: NCT01620749     History of Changes
Other Study ID Numbers: 10/11
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: June 2012

Keywords provided by Cooperative Research Centre for Biomedical Imaging Development:
melanoma metastatic diagnosis

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas