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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Radiation: FLT PET/CT
* Device: MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imaging studies<br>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<br>* 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).<br>Device: MRI<br>* MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leukemia, Lymphoma, Myeloma, Myelodysplastic Syndrome