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

NCT02042924 | Terminated Results DMC

• 2 other identifiers: 2013NTLS100MT2013-28R
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

Radiation: FLT PET/CT; Device: MRI

Interventions

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).

Imaging studies

MRI DEVICE

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

Imaging studies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Lymphoma; Neoplasms, Plasma Cell; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases

Results Point of Contact

• Title: Dr. Susanta Hui
• Organization: Masonic Cancer Center, University of Minnesota

shui@coh.org

626-218-0556

Study Officials

• Susanta K Hui, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 5, 2017
• Results First Posted: June 9, 2017

Record last verified: 2017-12

Locations

US (1)