FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer

NCT ID: NCT02317302

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-28
• Study Completion Date: 2020-06-02

Brief Summary

In this study, 50 evaluable patients will undergo one FDG-PET study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax, FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and heterogeneity during treatment will aid in better understanding the role of these biological parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging, have evaluated changes in the cervical tumor volume during treatment. The investigators expect there will be variation in how cervical tumors shrink and change during chemoradiation and therefore we are going to use multiple measures in addition to tumor volume to evaluate cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who are at higher risk for persistent disease following chemoradiation would allow for future studies where these high risk patients could be specifically targeted with more aggressive therapy.

Conditions

Cervical Cancer; Uterine Cervical Cancer; Uterine Cervical Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

FDG-PET/CT or FDG-PET/MR

• Standard of care FDG-PET/CT or FDG-PET/MR at baseline
• FDG-PET/CT or FDG-PET/MR after the 2nd but before the 3rd brachytherapy treatment
• Standard of care 3 month post treatment FDG-PET/CT or FDG-PET/MR
• We will perform the research-related FDG-PET on the PET/MR rather than the PET/CT if the patient is safe to undergo MR and agrees to undergo MR.
• The standard of care imaging may be performed on the PET/CT scanner or the PET/MR scanner.

Group Type: EXPERIMENTAL

FDG-PET/MR

Intervention Type: DEVICE

FDG-PET/CT

Intervention Type: DEVICE

Interventions

FDG-PET/MR

Intervention Type: DEVICE

FDG-PET/CT

Intervention Type: DEVICE

Other Intervention Names

PET/MR; PET/CT

Eligibility Criteria

Inclusion Criteria

• Patient must have biopsy-proven cervical cancer (FIGO stage-Ib2-IVb).
• Patient must be at least18 years of age.
• Patient must be planning to receive chemoradiation therapy with cisplatin.
• Patient must have non-pregnant status if a female of childbearing potential. Women who have had a tubal ligation at least 12 months prior to study entry or a hysterectomy will be considered NOT of childbearing potential. Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered NOT of childbearing potential.
• Patient may have distant metastatic disease provided the estimated survival is at least 1 year.
• Patient's tumor(s) must be FDG avid on baseline standard of care FDG-PET/CT or PET/MR imaging that was performed at Barnes-Jewish Hospital Clinical PET Facility.
• Patient must be able and willing to give informed consent.
• If the patient will be scanned on the PET/MR for the mid-treatment scan, they must be determined to be safe for exposure to the magnetic field. This will be determined the day of imaging by the technologist with the use of a screening form. If a patient is not safe for the PET/MR scanner, their mid-treatment images will occur on the PET/CT scanner in the Center for Clinical Imaging Research.

Exclusion Criteria

• Patient must have no other active cancer at the time of diagnosis of cervical cancer.
• Patient cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
• Patient must not be an uncontrolled diabetic with a glucose of ≥ 200mg/dl at the time of PET imaging.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Perry Grigsby, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

201104322

Identifier Type: -

Identifier Source: org_study_id