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

Not Applicable

Terminated

• Conditions: Hematologic Malignancy
• Interventions: Radiation: FLT PET/CT; Device: MRI

• Registration Number: NCT02042924
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-23
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2017-04-26
• Results First Submitted QC: 2017-06-07
• Results First Posted: 2017-06-09
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-03
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging studies	MRI	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.
Imaging studies	FLT PET/CT	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Minnesota Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States