Suitability of DCE-MRI for Detection of Vascular Changes... | NCT01991808

Studies
Suitability of DCE-MRI for Detection of Vascular Changes After VBT

NCT01991808

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Completed

Last Update Posted

Nov 26, 2019Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus

Interventions

Radiotherapy

Countries

United States

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

Participant Flow Module

Pre-assignment Details

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 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 8, 2016Actual

Completion Date

Dec 8, 2016Actual

First Submitted Date

Nov 11, 2013

First Submission Date that Met QC Criteria

Nov 18, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Oct 21, 2019

Results First Submitted that Met QC Criteria

Nov 25, 2019

Results First Posted Date

Nov 26, 2019Actual

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 25, 2019

Last Update Posted Date

Nov 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a pilot study of DCE MR imaging to detect vascular changes in the vagina during and after radiotherapy n patients receiving adjuvant brachytherapyfor cervical or endometrial cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Label	Type	Description	Intervention Names
DCE-MRI	Experimental		Radiation: Radiotherapy

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Radiation		DCE-MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be 18 years of age.
Must have histologically confirmed carcinoma of the cervix, carcinoma or carcinosarcoma of the uterus.
Subjects are receiving intracavitary brachytherapy.
ECOG performance status of 0-2.
Creatinine clearance 30.

Exclusion Criteria:

Subjects with an inability to tolerate MR imaging (i.e. claustrphobia)
Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants.
Patients who do not speak or read English.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

ID	Title	Description
FG000	DCE-MRI	Radiotherapy and dynamic contrast enhanced magnetic resonance imaging

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	DCE-MRI	Radiotherapy

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	DCE-MRI	Radiotherapy

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DCE-MRI	Radiotherapy	0

Serious Adverse Events

Not provided

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal distention	Gastrointestinal disorders		Non-systematic Assessment

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Yes

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Lilie Lin, MD	University of Pennsylvania	215-622-6515		lin@uphs.upenn.edu

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D002277	Carcinoma

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011878	Radiotherapy

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided