- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03065790
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
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1
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
-
-
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.
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
February 23, 2017
First Posted (ACTUAL)
February 28, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 4, 2021
Last Update Submitted That Met QC Criteria
June 1, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 54416
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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