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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton subjects |
| ||
| IMRT subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]Fluorothymidine (FLT) PET/CT Imaging | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Changes in Bone Marrow Assessed Through Images | up to 5 weeks |
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Inclusion Criteria:
Exclusion Criteria
Female subjects with diagnosed gynecologic cancer
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Female subjects with diagnosed gynecologic cancer
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| Name | Affiliation | Role |
|---|---|---|
| Lilie Lin, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Proton Subjects | [18F]Fluorothymidine (FLT) PET/CT Imaging |
| FG001 | IMRT Subjects | [18F]Fluorothymidine (FLT) PET/CT Imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proton Subjects | [18F]Fluorothymidine (FLT) PET/CT Imaging |
| BG001 | IMRT Subjects | [18F]Fluorothymidine (FLT) PET/CT Imaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients With Changes in Bone Marrow Assessed Through Images | Posted | Count of Participants | Participants | up to 5 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proton Subjects | [18F]Fluorothymidine (FLT) PET/CT Imaging | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lilie Lin, MD | University of Pennsylvania | 215-662-6515 | lin@xrt.upenn.edu |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | IMRT Subjects | [18F]Fluorothymidine (FLT) PET/CT Imaging | 0 | 12 | 0 | 12 | 4 | 12 |
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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