Of 18F MEL050 Using PET/CT in Metastatic Melanoma

NCT01620749 | Unknown Early Phase 1 DMC

• 1 other identifier: 10/11
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Melanoma

Keywords

melanoma metastatic diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• 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.

• Absorbed organ doses and whole body dose expressed as milliSv/200MBq administered dose.

  10, 30, 60 and 120 minutes post 18F MEL050 administration

Study Arms (1)

MEL050

EXPERIMENTAL

Radiation: 18F MEL050

Interventions

18F MEL050 RADIATION

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

MEL050

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cooperative Research Centre for Biomedical Imaging Development: lead

Study Sites (1)

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Grant McArthur

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2012
• First Posted: June 15, 2012
• Study Start: June 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 15, 2012

Record last verified: 2012-06

Locations

AU (1)