Early FDG PET/CT Imaging as a Measure of Response in Patients With Non-Hodgkin Lymphoma on Lenalidomide

June 1, 2021 updated by: Abramson Cancer Center of the University of Pennsylvania

Adult patients with non-Hodgkin lymphoma who will be treated with lenalidomide will undergo FDG PET/CT scan as an early evaluation of response to therapy. Changes in FDG uptake will be correlated response and long term outcomes.

Study Overview

Status

Terminated

Conditions

Non-Hodgkin Lymphoma

Intervention / Treatment

Diagnostic test: 2-Deoxy-2-[18F]fluoro-D-glucose (FDG)

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Non-Hodgkins Lymphoma

Description

Inclusion Criteria:

Adult patients, at least 18 years of age
History of histologically confirmed NHL as assessed per medical record review.
At least one site of measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT.
Recommended to start lenalidomide.
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine or serum pregnancy test at the time of the screening visit.
Inability to tolerate imaging procedures in the opinion of the investigator or treating physician.
Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of FDGmax SUV % change in FDG SUVmax Time Frame: 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 6, 2017

Primary Completion (ACTUAL)

April 28, 2021

Study Completion (ACTUAL)

April 28, 2021

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria