PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy
1. Age ≥18 years
2. Any subject with documented metastatic melanoma, RCC or NSCLC.
3. Subjects must be scheduled to receive therapy, or received only one dose, with an
anti-neoplastic agent that works by immune checkpoint blockade such as
ipilimumab/Yervoy (anti-CTLA-4), MDX-1106/BMS-936558 (anti-PD-1) or
MDX-1105/BMS-936559 (anti-B7-H1) mAbs.
4. Subjects must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension as >10 mm with spiral CT scan.
1. Patient is unable to provide informed consent
2. Patient is pregnant
3. Patient enrollment on research protocol which includes an additional mid-therapy
investigational FDG PET/CT at approximately month from start of therapy.
Type of Study:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Compare FDG PET-based qualitative and quantitative tumor response assessment with standard CT immune RECIST criteria
• To compare FDG PET-based qualitative and quantitative tumor response assessment with standard CT immune RECIST criteria in patients receiving immune checkpoint blockade therapy for melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC). Patients will receive 2 standard of care treatment FDG scans, the first scan at the begining of treatment and the second scan at the end of treatment. The research scan will be done between the first and second scan.
Outcome Time Frame:
6 months after completion of standard of care treatment
Steve Y Cho, MD
Johns Hopkins University
United States: Institutional Review Board
- Renal Cell Carcinoma (RCC)
- Non-Small Cell Lung Cancer (NSCLC)
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Renal Cell
- Lung Neoplasms
|Johns Hopkins University
||Baltimore, Maryland 21205