Status:
TERMINATED
FDG-PET in Advanced Melanoma
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Recurrent Melanoma
Stage IIIA Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 (C...
Detailed Description
PRIMARY OBJECTIVES: I. To correlate treatment-induced changes in FDG uptake with changes in tumor size and progression-free survival (PFS) in patients receiving therapy for advanced melanoma. II. To...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02236546
Start Date
May 1 2012
End Date
November 1 2015
Last Update
April 13 2017
Active Locations (1)
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1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232