Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus
Conditions
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.
Interventions
RADIATIONRadiotherapy
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DCE-MRI Radiotherapy | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | DCE-MRI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 63.5 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 10 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Number of Participants With Adverse Events
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DCE-MRI | Number of Participants With Adverse Events | 10 Participants |