Of 18F MEL050 Using PET/CT in Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Sponsor:
Cooperative Research Centre for Biomedical Imaging Development
Information provided by (Responsible Party):
Cooperative Research Centre for Biomedical Imaging Development
ClinicalTrials.gov Identifier:
NCT01620749
First received: May 27, 2012
Last updated: June 14, 2012
Last verified: June 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Metastatic Melanoma |
Radiation: 18F MEL050 |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Cooperative Research Centre for Biomedical Imaging Development:
Primary Outcome Measures:
- 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) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Percentage of injected 18F MEL050 dose in organs of interest. [ Time Frame: 10, 30, 60 and 120 minutes post 18F MEL050 administration ] [ Designated as safety issue: No ]
- Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration. [ Time Frame: 60, 120 and 180 minutes post 18F MEL050 administration. ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: MEL050 |
Radiation: 18F MEL050
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Cooperative Research Centre for Biomedical Imaging Development |
| ClinicalTrials.gov Identifier: | NCT01620749 History of Changes |
| Other Study ID Numbers: | 10/11 |
| Study First Received: | May 27, 2012 |
| Last Updated: | June 14, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
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 |
ClinicalTrials.gov processed this record on May 23, 2013