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| ID | Type | Description | Link |
|---|---|---|---|
| MT2013-28R | Other Identifier | University of Minnesota Blood and Marrow Transplant Program |
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Updating protocol and consents
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging studies | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLT PET/CT | Radiation | 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). |
| 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 |
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Inclusion Criteria:
Diagnosis of hematologic malignancy and fitting into one of the following categories:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Susanta K Hui, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful. | Posted | 100 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sweating | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susanta Hui | Masonic Cancer Center, University of Minnesota | 626-218-0556 | shui@coh.org |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| MRI | Device | MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days). |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Primary | Difference in Water Fat | The difference in the water-fat MRI between baseline and day 100 post transplant in L4 and femoral neck. | Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful. | Posted | 100 days |
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| 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 | Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful. | Posted | 100 days |
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| 0 |
| 2 |
| 1 |
| 2 |
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| D009370 |
| Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |