UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041491
Receipt number R000047370
Scientific Title The influence of stem cell source on dynamics of hematopoiesis and allogeneic hematopoietic cell transplantation outcome evaluated by 18F-FLT PET/MRI
Date of disclosure of the study information 2020/08/21
Last modified on 2020/08/21 02:04:20

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Basic information

Public title

The influence of stem cell source on dynamics of hematopoiesis and allogeneic hematopoietic cell transplantation outcome evaluated by 18F-FLT PET/MRI

Acronym

The influence of stem cell source on dynamics of hematopoiesis and allogeneic hematopoietic cell transplantation outcome evaluated by 18F-FLT PET/MRI

Scientific Title

The influence of stem cell source on dynamics of hematopoiesis and allogeneic hematopoietic cell transplantation outcome evaluated by 18F-FLT PET/MRI

Scientific Title:Acronym

The influence of stem cell source on dynamics of hematopoiesis and allogeneic hematopoietic cell transplantation outcome evaluated by 18F-FLT PET/MRI

Region

Japan


Condition

Condition

Leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, malignant lymphoma, multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We evaluate the dynamics of homing, engraftment, hematopoiesis and immune reconstitution used by 18F-FLT PET/MRI in allogeneic HCT patients. We analyze the influence of stem cell source, HLA mismatch, disease status, conditioning and GVHD prophylaxis on hematopoiesis process.

Basic objectives2

Others

Basic objectives -Others

We evaluate the dynamics of homing, engraftment, hematopoiesis and immune reconstitution used by 18F-FLT PET/MRI in allogeneic HCT patients. We analyze the influence of stem cell source, HLA mismatch, disease status, conditioning and GVHD prophylaxis on hematopoiesis process.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint is to access the characteristics of hematopoiesis process in BM, PB and CB transplantation patients. We evaluate regularly the standardized uptake value of whole-body bone marrow used by 18F-FLT PET/MRI during the pretransplant and first posttransplant year.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

We evaluate 18F-FLT PET/MRI during the phase of pretransplant, engraftment and posttransplant day +180. We also evaluate whole bone marrow MRI in the posttransplant day +100 and +365.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1 Patients aged 20 years or older at the time of obtaining consent
2 Hematological malignancy (Leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, malignant lymphoma and multiple myeloma) patients who receive allogeneic hematopoietic cell transplantation
3 Patients who, after receiving a sufficient explanation for participating in this study, have a sufficient understanding and have the free written consent of the patient (or a deputy if a deputy is required)

Key exclusion criteria

1 Patients who have Surgically implanted medical devices in the body (cardiac pacemaker, cochlear implant,
vascular stent, arterial clip, prosthetic joint, dental implant, magnetic dentures, etc.)
2 Pregnant women or patients who may be pregnant
3 Other patients who the investigator determined to be inappropriate as subjects

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Yamauchi

Organization

University of Fukui Hospital

Division name

Department of hematology and oncology

Zip code

910-1193

Address

23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

TEL

+81-776-61-3111

Email

araie116@u-fukui.ac.jp


Public contact

Name of contact person

1st name Hiroaki
Middle name
Last name Araie

Organization

University of Fukui Hospital

Division name

Department of hematology and oncology

Zip code

910-1193

Address

23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

TEL

+81-776-61-3111

Homepage URL


Email

araie116@u-fukui.ac.jp


Sponsor or person

Institute

University of Fukui

Institute

Department

Personal name



Funding Source

Organization

University of Fukui Hospital
Department of hematology and oncology
Biomedical imaging research center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Research Ethics Committee of University of Fukui

Address

23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui

Tel

+81-776-61-3111

Email

sm-kenkyusien@ml.u-fukui.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2020 Year 07 Month 14 Day

Date of IRB

2020 Year 07 Month 27 Day

Anticipated trial start date

2020 Year 08 Month 14 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 21 Day

Last modified on

2020 Year 08 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047370


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name