Gynecologic Cancer
Conditions
Keywords
concurrent chemotherapy
Brief summary
The purpose of this study is to determine the effect of specific bone marrow maps developed with18F-FLT PET/CT imaging on the ability to spare proliferating bone marrow using proton beam radiotherapy compared to IMRT. Participants will be 18 years of age or old with a history of gynecologic cancer. Subjects will undergo 3 FLT-PET scans (one before treatment, one during the course of RT, and one 2-5 weeks after initiation of RT). Scans will take place in the Department of Radiation Oncology.
Interventions
RADIATION[18F]Fluorothymidine (FLT) PET/CT Imaging
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants will be 18 years of age or older * History of gynecologic cancer. * Recommended to undergo IMRT or PBT of the pelvis with concurrent chemotherapy * Female participants of child-bearing potential must have a negative urine or serum pregnancy test at the time of the screening visit. * Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific procedures. * Participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician.
Exclusion criteria
* Females who are pregnant or breast feeding at the time of screening will not be eligible for this study. * Inability to tolerate imaging procedures in the opinion of the investigator or treating physician * Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subjects safety or successful participation in the study. * Unwilling or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients With Changes in Bone Marrow Assessed Through Images | up to 5 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proton Subjects \[18F\]Fluorothymidine (FLT) PET/CT Imaging | 3 |
| IMRT Subjects \[18F\]Fluorothymidine (FLT) PET/CT Imaging | 12 |
| Total | 15 |
Baseline characteristics
| Characteristic | Proton Subjects | IMRT Subjects | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 11 Participants | 13 Participants |
| Age, Continuous | 43.3 years STANDARD_DEVIATION 19.2 | 47.8 years STANDARD_DEVIATION 13.4 | 46.9 years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 11 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 7 Participants | 9 Participants |
| Region of Enrollment United States | 3 participants | 12 participants | 15 participants |
| Sex: Female, Male Female | 3 Participants | 12 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 12 |
| other Total, other adverse events | 0 / 3 | 4 / 12 |
| serious Total, serious adverse events | 0 / 3 | 0 / 12 |
Outcome results
Primary
Patients With Changes in Bone Marrow Assessed Through Images
Time frame: up to 5 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proton Subjects | Patients With Changes in Bone Marrow Assessed Through Images | 0 Participants |
| IMRT Subjects | Patients With Changes in Bone Marrow Assessed Through Images | 4 Participants |