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

NCT03065790 | Terminated DMC

• 1 other identifier: UPCC 54416
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of FDGmax SUV % change in FDG SUVmax

  2 years

Secondary Outcomes (1)

• Overall Survival

  2 years

Interventions

2-Deoxy-2-[18F]fluoro-D-glucose (FDG) DIAGNOSTIC_TEST

2-Deoxy-2-\[18F\]fluoro-D-glucose (FDG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Non-Hodgkins Lymphoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Michael Farwell, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: February 6, 2017
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

US (1)