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NCT01666353 · ClinicalTrials.gov registry record · Early Phase 1
PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy
A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT01666353 is a Early Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 20 participants.
The verdict
NCT01666353, a Early Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
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.
Interventions
- RADIATION PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-04-16 |
| Est. Completion | 2018-12-04 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01666353
The ClinicalTrials.gov registry entry for NCT01666353 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is the first listed.
NCT01666353 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01666353 about?
NCT01666353 is a clinical study titled "PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy". 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 tum...
What is the current status of trial NCT01666353?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2012-04-16. Estimated completion is 2018-12-04.
What interventions are being tested in trial NCT01666353?
The interventions under investigation include: PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) (RADIATION).
Who is sponsoring clinical trial NCT01666353?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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