Back to resultsSuitability of DCE-MRI for Detection of Vascular Changes After VBT
Primary Purpose
Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus
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.
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DCE-MRI
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT01991808
First Posted
November 11, 2013
Last Updated
November 25, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01991808
Brief Title
Suitability of DCE-MRI for Detection of Vascular Changes After VBT
Official Title
A Pilot Study to Assess the Suitability of DCE-MRI for Detection of Vascular Changes After Vaginal Brachytherapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 8, 2016 (Actual)
Study Completion Date
December 8, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DCE-MRI
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Suitability of DCE-MRI for Detection of Vascular Changes After VBT
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