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

NCT ID: NCT02042924

Last Updated: 2017-12-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-11-30

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.

Conditions

Hematologic Malignancy

Keywords

Leukemia; Lymphoma; Myeloma; Myelodysplastic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FLT PET/CT

Intervention Type: 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).

MRI

Intervention Type: DEVICE

MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).

Interventions

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).

Intervention Type: RADIATION

MRI

MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susanta K Hui, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

MT2013-28R

Identifier Type: OTHER

Identifier Source: secondary_id

2013NTLS100

Identifier Type: -

Identifier Source: org_study_id