- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02108457
[18F] Flourothymidine (FLT) PET/CT Imaging for Gynecologic Cancers
March 5, 2021 updated by: Abramson Cancer Center of the University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Female subjects with diagnosed gynecologic cancer
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Proton subjects
|
|
IMRT subjects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patients With Changes in Bone Marrow Assessed Through Images
Time Frame: up to 5 weeks
|
up to 5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lilie Lin, MD, Abramson Cancer Center of the University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
December 21, 2016
Study Completion (Actual)
December 21, 2016
Study Registration Dates
First Submitted
April 7, 2014
First Submitted That Met QC Criteria
April 8, 2014
First Posted (Estimate)
April 9, 2014
Study Record Updates
Last Update Posted (Actual)
March 30, 2021
Last Update Submitted That Met QC Criteria
March 5, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UPCC 28813
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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