UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004208
Receipt number R000005057
Scientific Title The exploratory study of F-18 FAZA PET/CT for patients with non-small cell lung cancer
Date of disclosure of the study information 2010/09/15
Last modified on 2020/03/23 13:10:02

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Basic information

Public title

The exploratory study of F-18 FAZA PET/CT for patients with non-small cell lung cancer

Acronym

FAZA PET/CT tests for patients with lung cancer

Scientific Title

The exploratory study of F-18 FAZA PET/CT for patients with non-small cell lung cancer

Scientific Title:Acronym

FAZA PET/CT tests for patients with lung cancer

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate clinical usefulness of F-18 FAZA PET/CT for patients with primary non-small cell lung cancer who are scheduled to receive curative treatments.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The accumulation of FAZA at the tumor

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

Medicine

Interventions/Control_1

F-18 FAZA PET/CT

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 non-small cell lung cancer either pathologically or cytologically.
2) The case whose primary lesion was no smaller than 1cm on CT images.
3) The case who was scheduled to receive a curative treatment such as surgery, radiation, chemotherapy and chemoradiotherapy.
4) The case to whom iodine contrast media can be injected.
5) The case who gave the written consent to join the study.
6) 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 HIROFUMI
Middle name
Last name FUJII

Organization

National Cancer Center Hospital East

Division name

Functional Imaging Division

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa

TEL

04-7134-6831

Email

fujii-rad@umin.org


Public contact

Name of contact person

1st name Hirofumi
Middle name
Last name Fujii

Organization

National Cancer Center Hospital East

Division name

Functional Imaging Division

Zip code

277-8577

Address

6-5-1 Kashiwanoha, Kashiwa

TEL

04-7134-6831

Homepage URL


Email

fujii-rad@umin.org


Sponsor or person

Institute

National Cancer Center

Institute

Department

Personal name



Funding Source

Organization

The Health and Labor Sciences Research Grants for Third Term Comprehensive 10-year Strategy for Cancer Control

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Office for Research Ethics, National Cancer Center

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045

Tel

03-3542-2511

Email

NCC@IRBofficeml.res.ncc.go.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

2010 Year 09 Month 15 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

Completed

Date of protocol fixation

2010 Year 08 Month 11 Day

Date of IRB

2010 Year 09 Month 08 Day

Anticipated trial start date

2010 Year 09 Month 13 Day

Last follow-up date

2015 Year 07 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

2010 Year 09 Month 14 Day

Last modified on

2020 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005057


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name