PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Skin Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/10/2019 |
| Start Date: | April 16, 2012 |
| End Date: | December 4, 2018 |
This study aims to develop methods for quantitative imaging of solid tumors in patients who
are receiving immunotherapies that have a delayed mechanism of action.
PET imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and
is able to detect melanomas and other tumors, some of which are undetectable by CT. FDG PET
is now used commonly in detecting melanoma in humans as melanomas quite consistently have
high glucose metabolism. PET with FDG can image the response of tumors to therapy, but has
not been extensively evaluated in melanoma nor in immunotherapy for melanoma. PET has been
shown to be highly predictive of outcomes of patients following radioimmunotherapy of
lymphoma, and has shown changes in tumor glycolysis as early as 7 days after immunotherapy
initiation.
In order to develop PET/CT as a tool to detect early evidence of response in patients with
solid tumors receiving immune checkpoint blockade, investigators propose to perform PET/CT
imaging prior to therapy, again between days 21 and 28, and finally at 4 months
post-treatment initiation. Each scan will be assessed qualitatively and quantitatively.
Investigators will use the PERCIST criteria to determine peak and maximum standardized uptake
values corrected for lean body mass (SUL) in tumor, tumor volumes, and tumor total glycolytic
volumes, and will use CT from PET/CT to measure tumor size by immune RECIST criteria. (See
section on Outcome Evaluation below.) Investigators will assess whether early changes in
tumor metabolism seen on FDG PET are predictive of progression free and overall survival
outcomes. Through these systematic pilot studies, investigators hope to better link FDG PET
measurements to individual patient responses to immune checkpoint blockade therapy and better
understand and refine this emerging and often effective therapeutic approach.
are receiving immunotherapies that have a delayed mechanism of action.
PET imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and
is able to detect melanomas and other tumors, some of which are undetectable by CT. FDG PET
is now used commonly in detecting melanoma in humans as melanomas quite consistently have
high glucose metabolism. PET with FDG can image the response of tumors to therapy, but has
not been extensively evaluated in melanoma nor in immunotherapy for melanoma. PET has been
shown to be highly predictive of outcomes of patients following radioimmunotherapy of
lymphoma, and has shown changes in tumor glycolysis as early as 7 days after immunotherapy
initiation.
In order to develop PET/CT as a tool to detect early evidence of response in patients with
solid tumors receiving immune checkpoint blockade, investigators propose to perform PET/CT
imaging prior to therapy, again between days 21 and 28, and finally at 4 months
post-treatment initiation. Each scan will be assessed qualitatively and quantitatively.
Investigators will use the PERCIST criteria to determine peak and maximum standardized uptake
values corrected for lean body mass (SUL) in tumor, tumor volumes, and tumor total glycolytic
volumes, and will use CT from PET/CT to measure tumor size by immune RECIST criteria. (See
section on Outcome Evaluation below.) Investigators will assess whether early changes in
tumor metabolism seen on FDG PET are predictive of progression free and overall survival
outcomes. Through these systematic pilot studies, investigators hope to better link FDG PET
measurements to individual patient responses to immune checkpoint blockade therapy and better
understand and refine this emerging and often effective therapeutic approach.
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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