UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005026
Receipt number R000005980
Scientific Title Comparison of findings between FDG PET/CT and FLT PET/CT in malignant tumor
Date of disclosure of the study information 2011/02/04
Last modified on 2011/02/16 15:31:02

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Basic information

Public title

Comparison of findings between FDG PET/CT and FLT PET/CT in malignant tumor

Acronym

Comparison of findings between FDG PET/CT and FLT PET/CT in malignant tumor

Scientific Title

Comparison of findings between FDG PET/CT and FLT PET/CT in malignant tumor

Scientific Title:Acronym

Comparison of findings between FDG PET/CT and FLT PET/CT in malignant tumor

Region

Japan


Condition

Condition

Digestive cancer (esophagus cancer, stomach cancer, large intestine cancer, and pancreatic carcinoma)

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Endocrinology and Metabolism Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Endocrine surgery Breast surgery Pediatrics
Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness of 18F FLT PET/CT by comparison with 18F FDG PET/CT in the same malignant tumors

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Both FLT and FDG-PET/CT images were evaluated visually and semiquantitatively by calculating the maximum standardized uptake value (SUVmax).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Medicine Device,equipment

Interventions/Control_1

FDG PET/CT image acquisition started 1 hour after intravenous administration of FDG, and after 3-7days FLT PET/CT image acquisition started 1 hour after intravenous administration of FLT

Interventions/Control_2

FLT PET/CT image acquisition started 1 hour after intravenous administration of FLT, and after 3-7days FDG PET/CT image acquisition started 1 hour after intravenous administration of FDG.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients with malignant tumor who are evaluated about staging before and after therapy.

Key exclusion criteria

None

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masatoyo Nakajo1, Yoriko Kajiya2

Organization

1 Kagoshima University, Graduate School of Medical and Dental Sciences
2 Nanpu hospital

Division name

Radiology

Zip code


Address

8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan

TEL

099-275-5417

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masatoyo Nakajo1, Yoriko Kajiya2

Organization

Nanpu hospital

Division name

Radiology

Zip code


Address

14-3 Nagata, Kagoshima 892-8512, Japan

TEL

099-226-9111

Homepage URL


Email

y.kajiya@nanpuh.or.jp


Sponsor or person

Institute

Nanpuh hospital

Institute

Department

Personal name



Funding Source

Organization

Nanpuh hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

Department of Radiology, Kagoshima University, Graduate School of Medical and Dental Sciences

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

南風病院(鹿児島県)


Other administrative information

Date of disclosure of the study information

2011 Year 02 Month 04 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

2010 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 Day

Last follow-up date

2014 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 02 Month 04 Day

Last modified on

2011 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005980


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name