Application of Integrated MR-PET in Patients With Gynecol... | NCT02292615

Studies
Application of Integrated MR-PET in Patients With Gynecologic Cancers

NCT02292615

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Nov 17, 2014Estimated

Enrollment

220Estimated

Phase

Not provided

Conditions

MR-PET Imaging

Interventions

Medical Imaging

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Apr 2014Actual

Completion Date

Not provided

First Submitted Date

Nov 12, 2014

First Submission Date that Met QC Criteria

Nov 12, 2014

First Posted Date

Nov 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2014

Last Update Posted Date

Nov 17, 2014Estimated

Description Module

Brief Summary

In this prospective cohort study, patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers) and patients with suspicious recurrent gynecologic cancers will be enrolled. The study period is two years and the estimated patient number is about 220. Patients will undergo image study before and after treatment. The diagnostic accuracy of MR-PET in cancer staging and the potential image biomarkers to monitor treatment response and predict treatment outcome will be investigated.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
cervical cancer	Group 1: Patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers).	Other: Medical Imaging
endometrial cancer	Group 2: Patients with suspicious recurrent gynecologic cancers (including cervical, endometrial, and ovarian cancers).	Other: Medical Imaging
ovarian cancer	Group 3: Patients with ovarian cancer who had debulking surgery and are going to receive adjuvant chemotherapy.	Other: Medical Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical Imaging	Other		cervical cancer endometrial cancer ovarian cancer

Measure	Description	Time Frame
The imaging biomarkers determined by MR-PET		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Group 1: Patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers).
Group 2: Patients with suspicious recurrent gynecologic cancers (including cervical, endometrial, and ovarian cancers).
Group 3: Patients with ovarian cancer who had debulking surgery and are going to receive adjuvant chemotherapy.

Exclusion Criteria:

Age <20 or >90 years old
Contraindication for MRI:
Contraindication for MR contrast medium (Cre > 2.0)
History of other malignancy
Prior arthroplasty of hip or pelvic bone surgery with metallic fixation (may cause artifacts on MRI)
Pregnant or lactating women

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

patients with newly diagnosed gynecologic cancers (including cervical, endometrial, and ovarian cancers) and patients with suspicious recurrent gynecologic cancers will be enrolled. The study period is two years and the estimated patient number is about 220.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tiffany Ting-Fang Shih, MD	Contact	886223123456	65568	ttfshih@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Tiffany Ting-Fang Shih, MD	Department of Medical Imaging, National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D014965	X-Rays

Ancestor Terms

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided