Of 18F MEL050 Using PET/CT in Metastatic Melanoma

NCT ID: NCT01620749

Last Updated: 2012-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F MEL050 for finding sites of melanoma.

Detailed Description

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Conditions

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Metastatic Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MEL050

Group Type EXPERIMENTAL

18F MEL050

Intervention Type RADIATION

Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.

Interventions

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18F MEL050

Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cooperative Research Centre for Biomedical Imaging Development

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grant McArthur

Role: PRINCIPAL_INVESTIGATOR

Peter MacCallum Cancer Centre, Australia

Locations

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Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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10/11

Identifier Type: -

Identifier Source: org_study_id

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