UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015413
Receipt number R000017927
Scientific Title Prospective study; Hypoxia imaging in lung cancer patients utilizing (18F)FAZA-PET/CT and 62Cu-ATSM PET/CT with reference to histopathology.
Date of disclosure of the study information 2014/10/18
Last modified on 2015/09/15 18:07:07

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Basic information

Public title

Prospective study; Hypoxia imaging in lung cancer patients utilizing (18F)FAZA-PET/CT and 62Cu-ATSM PET/CT with reference to histopathology.

Acronym

Hypoxia imaging in lung cancer patients utilizing (18F)FAZA-PET/CT

Scientific Title

Prospective study; Hypoxia imaging in lung cancer patients utilizing (18F)FAZA-PET/CT and 62Cu-ATSM PET/CT with reference to histopathology.

Scientific Title:Acronym

Hypoxia imaging in lung cancer patients utilizing (18F)FAZA-PET/CT

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate clinical usefulness of FAZA and ATSM PET for patients with primary lung cancer who are scheduled to receive curative resection.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Safety

Key secondary outcomes

The accumulation of FAZA and ATSM at the tumor


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) The case who was diagnosed as primary lung cancer either pathologically or cytologically.
2) The case who was scheduled to receive a curative resection.
3) The case to whom iodine contrast media can be injected.
4) The case who gave the written consent to join the study.
5) The case whose PS is between 0 and 2, the case who suffers from a serious illness except malignancy and the case who will become pregnant.

Key exclusion criteria

1) The case who is difficult to be included in the study due to psychological disorder and so on.
2) The case to whom the test agent cannot be injected due to iodine allergy and so on.
3) The case who is judged by the physician in charge not to be included in the study.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsutomo Kohno

Organization

Department of Surgery, Keio University School of Medicine

Division name

General thoracic surgery

Zip code


Address

35 Shinanomachi Shinjuku

TEL

0353633806

Email

kohno@a3.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsutomo Kohno

Organization

Department of Surgery, Keio University School of Medicine

Division name

General thoracic surgery

Zip code


Address

35 Shinanomachi Shinjuku

TEL

0353633806

Homepage URL


Email

kohno@a3.keio.jp


Sponsor or person

Institute

Division of General Thoracic Surgery, School of Medicine, Keio University

Institute

Department

Personal name



Funding Source

Organization

Division of General Thoracic Surgery, School of Medicine, Keio University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Functional Imaging Division, National Cancer Center Hospital East, Kashiwa, Japan

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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2014 Year 10 Month 11 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 11 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The result of this trial will be presented in academic meeting and article.


Management information

Registered date

2014 Year 10 Month 11 Day

Last modified on

2015 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017927


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name