Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus Clinical Trial
Official title:
A Pilot Study to Assess the Suitability of DCE-MRI for Detection of Vascular Changes After Vaginal Brachytherapy
| Verified date | November 2019 |
| Source | Abramson Cancer Center of the University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | December 8, 2016 |
| Est. primary completion date | December 8, 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | 2 years |