Pilot Study of Multi-Modality Imaging in Patients With Hematologic Malignancies

This is a pilot sub-study of patients receiving myeloablative transplant using total body irradiation (TBI) or total marrow irradiation (TMI) in their preparative regimen. The objective of this stub-study is to estimate the heterogeneity in cellular proliferation (FLT-PET uptake) as well the heterogeneity in marrow composition distribution (measured using whole body water-fat MRI) using positron emission tomography imaging. This will be used to design future trials as well as to determine the feasibility of PET and MRI imaging.

Study Overview

• Status: Terminated
• Conditions: Hematologic Malignancy
• Intervention / Treatment: Radiation: FLT PET/CT; Device: MRI

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Masonic Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of hematologic malignancy and fitting into one of the following categories:

  • Newly diagnosed and/or day 14 post-induction chemotherapy
  • Relapsed, including relapse after hematopoietic cell transplant
  • Planned hematopoietic cell transplant (if enrolling at "close") or within 100 days post hematopoietic cell transplant (if enrolling post-transplant) with a preparative regimen that includes either total marrow irradiation (TMI) or total body irradiation (TBI)
  • Undergoing natural killer cell therapies (with or without subsequent transplant)
• Aged 18 years and older
• Not pregnant - women of childbearing potential will have a confirmatory pregnancy test prior to each imaging per routine procedures
• Adequate renal function (estimated glomerular filtration rate > 60 ml/min) as determined by a serum creatinine level performed as a part of standard of care within 7 days of imaging
• Able and willing to provide written consent

Exclusion Criteria:

• Otherwise eligible patients meeting one or more of the contraindicates for an MRI, may enroll in the study without undergoing the MRI:

  • ferromagnetic implants
  • history of shrapnel or shot gun injury
  • too large to fit in the magnet (approximate body mass index ≥ 40)
  • cardiac pacemakers or other implanted devices that are not MR-compatible
  • claustrophobia
  • large tattoos

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imaging studies; Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.	Radiation: FLT PET/CT; Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).; Device: MRI; MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days	The difference in percentage of proliferating bone marrow will be calculated for the following sites: skull, proximal humeri, ribs, clavicles, cervical spine, thoracic spine, lumbar spine, sacrum, pelvis and proximal femur.	100 days
Difference in Water Fat	The difference in the water-fat MRI between baseline and day 100 post transplant in L4 and femoral neck.	100 days
Percentage of Proliferating Bone Marrow in the Femur	The difference in the percentage of proliferating bone marrow between baseline and day 100 post transplant in the femur	100 days

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Susanta K Hui, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): December 5, 2017
• Last Update Submitted That Met QC Criteria: December 3, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Lymphoma; Leukemia; Myeloma; Myelodysplastic Syndrome
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 2013NTLS100; MT2013-28R (Other Identifier: University of Minnesota Blood and Marrow Transplant Program)