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

NCT ID: NCT02108457

Last Updated: 2021-03-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-12-21

Brief Summary

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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

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Conditions

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Gynecologic Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Proton subjects

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

Intervention Type RADIATION

IMRT subjects

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

Intervention Type RADIATION

Interventions

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lilie Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 28813

Identifier Type: -

Identifier Source: org_study_id

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