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

Not Applicable

Completed

• Conditions: Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus

• Registration Number: NCT01991808
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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 available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Primary Completion: 2016-12-08
• Study Completion: 2016-12-08
• Results First Submitted: 2019-10-21
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Results First Posted: 2019-11-26
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	2 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States