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Completed

NCT Number: NCT02108457

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

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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Key information

Conditions

Gynecologic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Radiation

Primary outcomes

  1. Patients With Changes in Bone Marrow Assessed Through Images

    Time frame: up to 5 weeks

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 9, 2014
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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