CompletedEarly Phase 1NCT01666353
Official study title

PET Quantitative Assessments of Solid Tumor Response to Immune Checkpoint Blockade Therapy

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.

Ask AI to explain this study
Start here

Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedPET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 8, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Early Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study sponsor

01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Early Phase 1
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Interventions being studied
Radiation: PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Johns Hopkins UniversityBaltimore, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 8, 2019. Always confirm current availability with the study team.

View original record ↗