search
Back to results

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

Primary Purpose

Metastatic Melanoma

Status
Unknown status
Phase
Early Phase 1
Locations
Australia
Study Type
Interventional
Intervention
18F MEL050
Sponsored by
Cooperative Research Centre for Biomedical Imaging Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Melanoma focused on measuring melanoma metastatic diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peter MacCallum Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MEL050

Arm Description

Outcomes

Primary Outcome Measures

Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration.

Secondary Outcome Measures

Percentage of injected 18F MEL050 dose in organs of interest.
Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.
Absorbed organ doses and whole body dose expressed as milliSv/200MBq administered dose.

Full Information

First Posted
May 27, 2012
Last Updated
June 14, 2012
Sponsor
Cooperative Research Centre for Biomedical Imaging Development
search

1. Study Identification

Unique Protocol Identification Number
NCT01620749
Brief Title
Of 18F MEL050 Using PET/CT in Metastatic Melanoma
Acronym
MEL050
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 Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cooperative Research Centre for Biomedical Imaging Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
melanoma metastatic diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEL050
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
18F MEL050
Intervention Description
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Percentage of injected 18F MEL050 dose in organs of interest.
Time Frame
10, 30, 60 and 120 minutes post 18F MEL050 administration
Title
Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.
Time Frame
60, 120 and 180 minutes post 18F MEL050 administration.
Title
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. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant McArthur
Organizational Affiliation
Peter MacCallum Cancer Centre, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Of 18F MEL050 Using PET/CT in Metastatic Melanoma

We'll reach out to this number within 24 hrs