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

Primary Purpose

Hematologic Malignancy

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FLT PET/CT
MRI
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hematologic Malignancy focused on measuring Leukemia, Lymphoma, Myeloma, Myelodysplastic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Masonic Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imaging studies

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Difference in Water Fat
The difference in the water-fat MRI between baseline and day 100 post transplant in L4 and femoral neck.
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

Secondary Outcome Measures

Full Information

First Posted
January 21, 2014
Last Updated
December 3, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02042924
Brief Title
Pilot Study of Multi-Modality Imaging in Patients With Hematologic Malignancies
Official Title
Pilot Study of Multi-Modality Imaging in Patients With Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Updating protocol and consents
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy
Keywords
Leukemia, Lymphoma, Myeloma, Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imaging studies
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
FLT PET/CT
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
Primary Outcome Measure Information:
Title
Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days
Description
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.
Time Frame
100 days
Title
Difference in Water Fat
Description
The difference in the water-fat MRI between baseline and day 100 post transplant in L4 and femoral neck.
Time Frame
100 days
Title
Percentage of Proliferating Bone Marrow in the Femur
Description
The difference in the percentage of proliferating bone marrow between baseline and day 100 post transplant in the femur
Time Frame
100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanta K Hui, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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