Hematologic MalignancyNCT02042924

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

A study testing FLT PET/CT and MRI in people with Hematologic Malignancy, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematologic Malignancy
What is being tested?: FLT PET/CT and MRI
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Jan 2014to Nov 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

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
Being tested: FLT PET/CT, MRI
Keywords: Leukemia, Lymphoma, Myeloma, Myelodysplastic Syndrome
Medical subject headings: Hematologic Neoplasms, Leukemia, Lymphoma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02042924
Study group	Role	What they receive
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. Receives: Radiation: FLT PET/CT; Device: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 100 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Nov 2015

First posted23 Jan 2014 (estimated)
Study startJan 2014
Primary completionNov 2015
Study completionNov 2015

Why it stopped: Updating protocol and consents

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02042924
Sponsor's protocol ID: 2013NTLS100
Other IDs: MT2013-28R
Status last verified: Dec 2017
First submitted: 21 Jan 2014
Last updated: 5 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hematologic Malignancy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Multi-Modality Imaging in Patients With Hematologic Malignancies
ClinicalTrials.gov ID: NCT02042924
Acronym / sponsor ID: 2013NTLS100
Conditions: Hematologic Malignancy
Keywords: Leukemia, Lymphoma, Myeloma, Myelodysplastic Syndrome
Study type: Interventional
Recruitment status: TerminatedReason stopped: Updating protocol and consents
Enrolment: 2 participants (actual)
Lead sponsor: Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
Study start: Jan 2014
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 23 Jan 2014 (estimated)
Results: Posted 9 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Imaging studies	Experimental	Radiation: FLT PET/CT, Device: MRISubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Diagnosis of hematologic malignancy and fitting into one of the following categories:
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

Key exclusion criteria (7 listed)

Otherwise eligible patients meeting one or more of the contraindicates for an MRI, may enroll in the study without undergoing the MRI:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FLT PET/CTFunctional 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).	Radiation	Imaging studies
MRIMRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).	Device	Imaging studies

Primary outcome

Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days
Time frame: 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
Time frame: 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
Time frame: 100 days
The difference in the percentage of proliferating bone marrow between baseline and day 100 post transplant in the femur

Results and safety

Results posted to the registry on 9 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Imaging Studies	2	1

Primary outcome: Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days

Time frame: 100 days

Population analysed: Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.

Primary outcome: Difference in Water Fat

Time frame: 100 days

Population analysed: Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.

Primary outcome: Percentage of Proliferating Bone Marrow in the Femur

Time frame: 100 days

Population analysed: Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Imaging Studies	0 of 2 (0%)	1 of 2 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hematologic Malignancy

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A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susanta K Hui, PhD principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FLT PET/CT and MRI in people with Hematologic Malignancy, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days (time frame: 100 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02042924.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.