UnknownEarly Phase 1

Of 18F MEL050 Using PET/CT in Metastatic Melanoma

Australia12 participantsStarted 2010-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 28 days following 18F MEL050 administration (+/- 7 days)

Trial details

NCT IDNCT01620749

SponsorCooperative Research Centre for Biomedical Imaging Development

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03

View on ClinicalTrials.gov More Metastatic Melanoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.