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

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ClinicalTrials.gov Identifier: NCT01991808
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus Radiation: Radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Assess the Suitability of DCE-MRI for Detection of Vascular Changes After Vaginal Brachytherapy
Study Start Date : October 2013
Actual Primary Completion Date : December 8, 2016
Actual Study Completion Date : December 8, 2016


Arm Intervention/treatment
Experimental: DCE-MRI Radiation: Radiotherapy



Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991808


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01991808     History of Changes
Other Study ID Numbers: UPCC 26812
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Carcinosarcoma
Mixed Tumor, Mullerian
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Sarcoma
Neoplasms, Connective and Soft Tissue