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

NCT ID: NCT01991808

Last Updated: 2019-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-12-08

Brief Summary

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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

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Conditions

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Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DCE-MRI

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

Interventions

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Radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 26812

Identifier Type: -

Identifier Source: org_study_id

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