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Of 18F MEL050 Using PET/CT in Metastatic Melanoma

C

Cooperative Research Centre for Biomedical Imaging Development

Status and phase

Unknown
Early Phase 1

Conditions

Metastatic Melanoma

Treatments

Radiation: 18F MEL050

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

MEL050
Experimental group
Treatment:
Radiation: 18F MEL050

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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