PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy
|ClinicalTrials.gov Identifier: NCT01666353|
Recruitment Status : Unknown
Verified March 2015 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was: Active, not recruiting
First Posted : August 16, 2012
Last Update Posted : March 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Renal Cell Carcinoma (RCC) Non-small Cell Lung Cancer (NSCLC)||Radiation: PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Experimental: Therapeutic response for solid tumors
Adult patients, with documented metastatic melanoma, RCC or NSCLC, about to initiate any line of immune checkpoint blockade therapy will receive a FDG PET scan during mid treatment to check for change in disease.
Radiation: PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG)
PET/CT 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.
- Compare FDG PET-based qualitative and quantitative tumor response assessment with standard CT immune RECIST criteria [ Time Frame: 6 months after completion of standard of care treatment ]• 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.
- Assess the use of FDG PET as a non-invasive imaging method to detect early evidence of organ inflammation [ Time Frame: 6 months after completion of standard of care treatment ]
- To compare FDG PET-derived SUV-based tumor metabolic activity in patients with prolonged stable partial responses to immune checkpoint blockade
- To assess the use of FDG PET as a non-invasive imaging method to detect early evidence of organ inflammation in patients receiving immune checkpoint blockade therapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666353
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Evan Lipson, MD||Johns Hopkins University|