UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018058
Receipt number R000020909
Scientific Title Molecular imaging of DNA synthesis using a new PET tracer: clinical study of diagnosis and therapeutic assessment for esophageal cancer
Date of disclosure of the study information 2015/07/10
Last modified on 2019/03/18 19:28:19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Molecular imaging of DNA synthesis using a new PET tracer: clinical study of diagnosis and therapeutic assessment for esophageal cancer

Acronym

Diagnosis and therapeutic assessment for esophageal cancer with molecular imaging of DNA synthesis

Scientific Title

Molecular imaging of DNA synthesis using a new PET tracer: clinical study of diagnosis and therapeutic assessment for esophageal cancer

Scientific Title:Acronym

Diagnosis and therapeutic assessment for esophageal cancer with molecular imaging of DNA synthesis

Region

Japan


Condition

Condition

Esophageal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the utility of 4DST-PET for diagnosis, treatment planning and therapeutic assessment of esophageal cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

To explore how 4DST-PET can contribute to initial diagnosis, treatment planning and therapeutic assessment of esophageal cancer.

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

Other

Interventions/Control_1

The patients undergo both 4DST- and FDG-PET studies. The findings will be compared reciprocally. In the procedure, other examinations including histopathological findings and other radiological images are referred.

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) Patient who is pathologically diagnosed as esophageal cancer.
2) Age, elder than or equal to 20 years.
3) Capability to undergo PET scan.
4) Completed the written informed consent.

Key exclusion criteria

1) Unable to have signed informed consent.
2) Patient with severe comorbid disease including liver dysfunction, renal dysfunction or metabolic damage.
3) Uncontrollable diabetics.
4) Those who are determined as not appropriate for the study by the principal investigator.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryogo Minamimoto

Organization

National Center for Global Health and Medicine

Division name

Department of Nuclear Medicine

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Email

rminamimoto@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryogo Minamimoto

Organization

National Center for Global Health and Medicine

Division name

Department of Nuclear Medicine

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Homepage URL


Email

rminamimoto@hosp.ncgm.go.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 10 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

2015 Year 07 Month 01 Day

Date of IRB

2015 Year 07 Month 01 Day

Anticipated trial start date

2015 Year 07 Month 15 Day

Last follow-up date

2019 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

2015 Year 06 Month 24 Day

Last modified on

2019 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020909


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name