N/A
N=16
Suitability of DCE-MRI for Detection of Vascular Changes After VBT
Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus
Bottom Line
View on ClinicalTrials.gov: NCT01991808 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Number of Participants With Adverse Events — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
10 | — |
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.
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 0-2.
- 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.
Data sourced from ClinicalTrials.gov (NCT01991808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.