Clinical trial · Interventional
FDG-PET in Advanced Melanoma
FDG-PET/CT as a Biomarker for Treatment Response in Advanced Melanoma
NCT02236546CI-TRIAL-00026966terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): loss of funding
Summary
Brief summary (as posted)
This clinical trial studies how well FDG-PET/CT measures early response in patients with stage III-IV melanoma who are receiving chemotherapy. Positron emission tomography (PET)/computed tomography (CT) uses a metabolic imaging radiotracer, \[18F\]fluorodeoxyglucose (FDG), which selectively accumulates in tumors. FDG-PET/CT of advanced melanoma before, during, and after treatment may improve methods for predicting which patients may benefit from therapy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]fluorodeoxyglucose | Diagnostic Test | — | UNRESOLVED |
| computed tomography | Device | — | UNRESOLVED |
| Molecular assays on biopsied tissue | Other | — | UNRESOLVED |
| positron emission tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FDG-PET/CT
- description
- Patients undergo \[18F\]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.
- interventionNames
- Diagnostic Test: [18F]fluorodeoxyglucose
- Other: Molecular assays on biopsied tissue
- Device: positron emission tomography
- Device: computed tomography
Primary outcomes (1)
- measure
- Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST
- timeFrame
- Baseline to the completion of 6 courses of treatment
- description
- The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must have signed Institutional Review Board (IRB)-approved informed consent documentation * Subjects must be diagnosed with histologically proven stage IV (metastatic) melanoma or stage III with bulky disease which may or may not be amenable for surgery and are receiving therapy at present * Subjects must be scheduled to begin treatment through the Vanderbilt-Ingram Cancer Center (VICC) Melanoma Program; this will include patients receiving standard-of-care chemotherapy, targeted therapy, and/or immunotherapy, as well as patients accrued to VICC clinical trials for the study of investigational agents * Subjects must have measurable disease by CT or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; to comply with PET Response Criteria in Solid Tumors (PERCIST) criteria, subjects should have at least one lesion measuring at least 2 cm in the longest diameter Exclusion Criteria: * Subjects who are pregnant or nursing; urine pregnancy test/or serum human chorionic gonadotropin (HCG) will be performed on women of child bearing potential * Subjects who have experienced allergic or other adverse reactions in response to intravenous injection of fluorinated radiotracers and other contrast media used in PET/CT * Subjects incapable of giving informed written consent, for the following reasons: * Inability to adhere to the experimental protocols for any reason * Inability to communicate with the research team * Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders * Prisoners or other individuals deemed to be susceptible to coercion
References
Publications (0)
Data not yet available
No reference posted for this study.