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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00897923
Date of registration: 09/05/2009
Prospective Registration: No
Primary sponsor: Mayo Clinic
Public title: Imaging of Radiolabeled White Blood Cells in Patients With Non-Hodgkin's Lymphoma
Scientific title: In Vivo Imaging of Effector Cells in Anti-Lymphoma Therapy
Date of first enrolment: September 2003
Target sample size: 17
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00897923
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Gregory Wiseman, MD
Address: 
Telephone:
Email:
Affiliation:  Mayo Clinic
Name:     Michael M. Graham, PhD, MD
Address: 
Telephone:
Email:
Affiliation:  Holden Comprehensive Cancer Center
Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-Hodgkin's lymphoma

- Indolent or aggressive disease

- Planning to receive a new regimen or starting a regimen of cancer therapy

- At least one tumor lesion measurable in two dimensions as = 1.5 cm by CT scan

PATIENT CHARACTERISTICS:

- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

- Life expectancy = 3 months

- No concurrent medical complications that would preclude study compliance

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

- At least 3 weeks since prior chemotherapy (except for nonmyelosuppressive treatments)

- At least 3 weeks since prior radiation therapy

- Concurrent rituximab allowed



Age minimum: 18 Years
Age maximum: 120 Years
Gender: All
Health Condition(s) or Problem(s) studied
Small Intestine Cancer
Lymphoma
Intervention(s)
Radiation: indium In 111-labeled autologous polymorphonuclear leukocytes
Radiation: indium In 111-labeled autologous peripheral blood mononuclear cells
Procedure: radionuclide imaging
Primary Outcome(s)
Cellular uptake of PBMCs and PMNLs as measured by reader/visual interpretation, semiquantitative grading system, and tumor-to-background uptake ratios
Number of baseline indium In 111-labeled peripheral blood mononuclear cells (PBMCs) trafficking into tumors
Number of baseline indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into tumors
Number of PBMC and PMNL trafficking prior to vs after therapy
Secondary Outcome(s)
Secondary ID(s)
CDR0000529768
MAYO-IRB-1414-03
UIHC-LS0383
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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