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

Non-Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03065790
• Other study ID #: UPCC 54416
• Status: Terminated
• Start date: February 6, 2017
• Est. completion date: April 28, 2021

Study information

• Verified date: June 2021
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of FDGmax SUV % change in FDG SUVmax		2 years
Secondary	Overall Survival		2 years