UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028332
Receipt number R000032427
Scientific Title Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole
Date of disclosure of the study information 2017/07/24
Last modified on 2023/01/25 09:51:25

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Basic information

Public title

Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole

Acronym

Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole

Scientific Title

Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole

Scientific Title:Acronym

Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the change of tumor hypoxia in lung cancer using 18F-fluoromisonidazole after stereotactic radiotherapy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of 18F-MISO uptake between before and after treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

To perform F-MISO PET/CT before and 1 day after treatment

Interventions/Control_2

To perform F-MISO PET/CT before and 2 day after treatment

Interventions/Control_3

To perform F-MISO PET/CT before and 3 day after treatment

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

1)Adaptable of stereotactic radiotherapy for primary or metastatic lung malignant tumor less of equal 5cm. Fulfilling both of the following conditions and clinically diagnosed as NSCLC.
a) increase in tumor size of 1 mm or more, or consolidation/tumor ratio turning >50% from <=50% on CT scans performed 28 days or more apart.
b) positive accumulation on FDG-PET.
2)Performance status (ECOG): 0-2
3)Enable for performing PET/CT
4)Aged 20 to 84
5)signed informed consent

Key exclusion criteria

1)During the pregnancy or a pregnant female patient we are possible or are nursing.
2)The patient whom we merge psychosis or neurological manifestation, and it is judged to have difficulty with participation to an examination.
3)Severe complications whom enable to perform PET/CT
4)Other reasons with inadequate to enroll this trial

Target sample size

18


Research contact person

Name of lead principal investigator

1st name Yasumasa
Middle name
Last name Nishimura

Organization

Kindai University

Division name

Department of Radiation Oncology,

Zip code

5898511

Address

377-2,ohnohigashi,osakasayamashi,osaka

TEL

072-366-0221

Email

im022012@med.kindai.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Inada

Organization

Kindai University

Division name

Department of Radiation Oncology,

Zip code

5898511

Address

377-2,ohnohigashi,osakasayamashi,osaka

TEL

072-366-0221

Homepage URL


Email

im022012@med.kindai.ac.jp


Sponsor or person

Institute

Kindai University

Institute

Department

Personal name



Funding Source

Organization

Kindai University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kindai Univarsity Faclty of medicine

Address

Ohnohigashi 377-2, Osakasayama city, Osaka

Tel

0723880221

Email

im022012@med.kindai.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

2017 Year 07 Month 24 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

15

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

Main results already published

Date of protocol fixation

2017 Year 03 Month 08 Day

Date of IRB

2016 Year 11 Month 08 Day

Anticipated trial start date

2017 Year 03 Month 08 Day

Last follow-up date

2023 Year 03 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 07 Month 22 Day

Last modified on

2023 Year 01 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032427


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name