[18F] Flourothymidine (FLT) PET/CT Imaging for Gynecologic Cancers

Completed

• Conditions: Gynecologic Cancer
• Interventions: Radiation: [18F]Fluorothymidine (FLT) PET/CT Imaging

• Registration Number: NCT02108457
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-09
• Primary Completion: 2016-12-21
• Study Completion: 2016-12-21
• Results First Submitted: 2019-10-21
• Results First Submitted QC: 2019-10-21
• Results First Posted: 2019-11-08
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-05
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IMRT subjects	[18F]Fluorothymidine (FLT) PET/CT Imaging	-
Proton subjects	[18F]Fluorothymidine (FLT) PET/CT Imaging	-

Primary Outcome Measures

Name	Time	Method
Patients With Changes in Bone Marrow Assessed Through Images	up to 5 weeks

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States