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

University of Minnesota (UMN)

Status: Terminated

Conditions: Hematologic Malignancy

Treatments: Device: MRI; Radiation: FLT PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02042924

2013NTLS100

MT2013-28R (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Imaging studies

Experimental group

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.

Treatment:

Radiation: FLT PET/CT

Device: MRI