Of 18F MEL050 Using PET/CT in Metastatic Melanoma | NCT01620749

Studies
Of 18F MEL050 Using PET/CT in Metastatic Melanoma

NCT01620749

Sponsor

Cooperative Research Centre for Biomedical Imaging Development

Status

Unknown status

Last Update Posted

Jun 15, 2012Estimated

Enrollment

12Actual

Phase

Early Phase 1

Conditions

Metastatic Melanoma

Interventions

18F MEL050

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Mar 2012Actual

Completion Date

Dec 2012Estimated

First Submitted Date

May 27, 2012

First Submission Date that Met QC Criteria

Jun 14, 2012

First Posted Date

Jun 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2012

Last Update Posted Date

Jun 15, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MEL050	Experimental		Radiation: 18F MEL050

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F MEL050	Radiation	Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.	MEL050

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration.		Up to 28 days following 18F MEL050 administration (+/- 7 days)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of injected 18F MEL050 dose in organs of interest.		10, 30, 60 and 120 minutes post 18F MEL050 administration
Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.		60, 120 and 180 minutes post 18F MEL050 administration.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Grant McArthur	Peter MacCallum Cancer Centre, Australia	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Peter MacCallum Cancer Centre		East Melbourne	Victoria	3002	Australia

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided