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

NCT02108457 | Completed Results DMC

• 1 other identifier: UPCC 28813
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Keywords

concurrent chemotherapy

Outcome Measures

Primary Outcomes (1)

• Patients With Changes in Bone Marrow Assessed Through Images

  up to 5 weeks

Study Arms (2)

Proton subjects

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

IMRT subjects

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

Interventions

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

IMRT subjects; Proton subjects

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female subjects with diagnosed gynecologic cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects with diagnosed gynecologic cancer

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Results Point of Contact

• Title: Lilie Lin, MD
• Organization: University of Pennsylvania

lin@xrt.upenn.edu

215-662-6515

Study Officials

• Lilie Lin, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 9, 2014
• Study Start: February 1, 2014
• Primary Completion: December 21, 2016
• Study Completion: December 21, 2016
• Last Updated: March 30, 2021
• Results First Posted: November 8, 2019

Record last verified: 2021-03

Locations

US (1)