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

NCT01666353 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-02-08

No results posted yet for this 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.

Conditions

  • Melanoma
  • Renal Cell Carcinoma (RCC)
  • Non-small Cell Lung Cancer (NSCLC)

Interventions

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.

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

  • Melanoma Research Alliance

    collaborator OTHER

Principal Investigators

  • Evan Lipson, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-16
Primary Completion
2014-06-02
Completion
2018-12-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01666353 on ClinicalTrials.gov