Metastatic MelanomaEarly Phase 1MEL050NCT01620749
Of 18F MEL050 Using PET/CT in Metastatic Melanoma
A Early Phase 1 study testing 18F MEL050 in people with Metastatic Melanoma, run by Cooperative Research Centre for Biomedical Imaging Development at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- 18F MEL050
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2010to Dec 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Australia1 site
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
About this study
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
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
- Being tested
- 18F MEL050
- Keywords
- melanoma metastatic diagnosis
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F MEL050Radiation
Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.
| Study group | Role | What they receive |
|---|---|---|
| MEL050 | Experimental | Not described Receives: Radiation: 18F MEL050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration.
Measured: Up to 28 days following 18F MEL050 administration (+/- 7 days)
Secondary outcomes (3)
Percentage of injected 18F MEL050 dose in organs of interest.
Measured: 10, 30, 60 and 120 minutes post 18F MEL050 administration
Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.
Measured: 60, 120 and 180 minutes post 18F MEL050 administration.
Absorbed organ doses and whole body dose expressed as milliSv/200MBq administered dose.
Measured: 10, 30, 60 and 120 minutes post 18F MEL050 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooperative Research Centre for Biomedical Imaging Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grant McArthur, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620749
- Sponsor's protocol ID
- 10/11
- Acronym
- MEL050
- Status last verified
- Jun 2012
- First submitted
- 27 May 2012
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01620749
- Acronym / sponsor ID
- MEL050 / 10/11
- Conditions
- Metastatic Melanoma
- Keywords
- melanoma metastatic diagnosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cooperative Research Centre for Biomedical Imaging DevelopmentUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 15 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F MEL050 for finding sites of melanoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEL050 | Experimental | Radiation: 18F MEL050 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F MEL050Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma. | Radiation | MEL050 |
Primary outcome
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)
3 secondary outcomes
Percentage of injected 18F MEL050 dose in organs of interest.
Time frame: 10, 30, 60 and 120 minutes post 18F MEL050 administration
Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.
Time frame: 60, 120 and 180 minutes post 18F MEL050 administration.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant McArthur principal investigator
Peter MacCallum Cancer Centre, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F MEL050 in people with Metastatic Melanoma, run by Cooperative Research Centre for Biomedical Imaging Development at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2012.