NCT01991808CompletedNot Applicable
A Pilot Study to Assess the Suitability of DCE-MRI for Detection of Vascular Changes After Vaginal Brachytherapy
Abramson Cancer Center at Penn Medicine1 site in 1 country16 target enrollmentStarted: October 1, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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-
- •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.
Arms & Interventions
DCE-MRI
Experimental
Intervention: Radiotherapy (Radiation)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events
Time Frame: 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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