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

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02042924
• Other study ID #: 2013NTLS100
• Secondary ID: MT2013-28R
• Status: Terminated
• Phase: N/A
• First received: January 21, 2014
• Last updated: December 3, 2017
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Neoplasms

Intervention

Radiation:
• 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).

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

Locations

Country	Name	City	State
United States	University of Minnesota Masonic Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	100 days
Primary	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
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	100 days