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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108457
• Other study ID #: UPCC 28813
• Status: Completed
• Start date: February 2014
• Est. completion date: December 21, 2016

Study information

• Verified date: March 2021
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 21, 2016
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Radiation:
• [18F]Fluorothymidine (FLT) PET/CT Imaging

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients With Changes in Bone Marrow Assessed Through Images		up to 5 weeks