Hematologic Malignancy
Conditions
Keywords
Leukemia, Lymphoma, Myeloma, Myelodysplastic Syndrome
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.
Interventions
RADIATIONFLT 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).
DEVICEMRI
MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days | 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 | 100 days | 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 | 100 days | The difference in the percentage of proliferating bone marrow between baseline and day 100 post transplant in the femur |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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).
MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days). | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Early Death | 1 |
Baseline characteristics
| Characteristic | Imaging Studies |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
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.
Time frame: 100 days
Population: Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.
Primary
Difference in Water Fat
The difference in the water-fat MRI between baseline and day 100 post transplant in L4 and femoral neck.
Time frame: 100 days
Population: Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.
Primary
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
Time frame: 100 days
Population: Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.