N/A
N=15
[18F] Flourothymidine (FLT) PET/CT Imaging for Gynecologic Cancers
Gynecologic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02108457 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Patients With Changes in Bone Marrow Assessed Through Images — 0; 4 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- [18F]Fluorothymidine (FLT) PET/CT Imaging (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 Patients With Changes in Bone Marrow Assessed Through Images |
0; 4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02108457). 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.