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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Melanoma | Radiation: 18F MEL050 | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: MEL050 |
Radiation: 18F MEL050
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma. |
- 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) ]
- Percentage of injected 18F MEL050 dose in organs of interest. [ Time Frame: 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. ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Australia, Victoria | |
Peter MacCallum Cancer Centre | |
East Melbourne, Victoria, Australia, 3002 |
Principal Investigator: | Grant McArthur | Peter MacCallum Cancer Centre, Australia |
Responsible Party: | Cooperative Research Centre for Biomedical Imaging Development |
ClinicalTrials.gov Identifier: | NCT01620749 |
Other Study ID Numbers: |
10/11 |
First Posted: | June 15, 2012 Key Record Dates |
Last Update Posted: | June 15, 2012 |
Last Verified: | June 2012 |
melanoma metastatic diagnosis |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |