Clinical trial · Interventional
Of 18F MEL050 Using PET/CT in Metastatic Melanoma
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
NCT01620749CI-TRIAL-00007203MEL050unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F MEL050 | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MEL050
- interventionNames
- Radiation: 18F MEL050
Primary outcomes (1)
- measure
- 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)
Secondary outcomes (3)
- measure
- Percentage of injected 18F MEL050 dose in organs of interest.
- timeFrame
- 10, 30, 60 and 120 minutes post 18F MEL050 administration
- measure
- Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.