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Clinical Trials/NCT01991808
NCT01991808
Completed
Not 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 enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus
Sponsor
Abramson Cancer Center at Penn Medicine
Enrollment
16
Locations
1
Primary Endpoint
Number of Participants With Adverse Events
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
December 8, 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

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-
  • 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.

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

Time Frame: 2 years

Study Sites (1)

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