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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 : Unknown
Verified April 2016 by Abramson Cancer Center of the University of Pennsylvania.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : April 13, 2016
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 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
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
Estimated Primary Completion Date : October 2017





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


Contacts
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Contact: Lilie Lin, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Lilie Lin, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Lilie Lin, MD         
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 13, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
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Carcinosarcoma
Mixed Tumor, Mullerian
Uterine Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Connective and Soft Tissue
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female