Trial Outcomes & Findings for Pilot Study of Multi-Modality Imaging in Patients With Hematologic Malignancies (NCT NCT02042924)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

100 days

Results posted on

2017-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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). MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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). MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
Overall Study Early Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Imaging Studies n=1 Participants 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. 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). MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 100 days

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

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 100 days

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

The difference in the water-fat MRI between baseline and day 100 post transplant in L4 and femoral neck.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 100 days

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

The difference in the percentage of proliferating bone marrow between baseline and day 100 post transplant in the femur

Outcome measures

Outcome data not reported

Adverse Events

Imaging Studies

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Imaging Studies n=2 participants at risk 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. 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). MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
General disorders Sweating	50.0% 1/2

Additional Information

Dr. Susanta Hui

Masonic Cancer Center, University of Minnesota

Phone: 626-218-0556

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place