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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Terminated
CT.gov ID
NCT03065790
Collaborator
(none)
1
Enrollment
1
Location
50.7
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 2-Deoxy-2-[18F]fluoro-D-glucose (FDG)

Study Design

Study Type:
Observational
Actual Enrollment :
1 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Early FDG PET/CT Imaging as a Measure of Response in Patients With Non-Hodgkin Lymphoma on Lenalidomide
Actual Study Start Date :
Feb 6, 2017
Actual Primary Completion Date :
Apr 28, 2021
Actual Study Completion Date :
Apr 28, 2021

Outcome Measures

Primary Outcome Measures

  1. Number of FDGmax SUV % change in FDG SUVmax [2 years]

Secondary Outcome Measures

  1. Overall Survival [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Michael Farwell, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03065790
Other Study ID Numbers:
  • UPCC 54416
First Posted:
Feb 28, 2017
Last Update Posted:
Jun 4, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of Jun 4, 2021