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

FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response to Concurrent Radiation Therapy and Chemotherapy in Patients With Cervical Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Cervical Cancer; Uterine Cervical Neoplasms; Uterine Cervical Cancer
• Intervention / Treatment: Device: FDG-PET/MR; Device: FDG-PET/CT

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: FDG-PET/MR; Other Names: PET/MR; Device: FDG-PET/CT; Other Names: PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FDG heterogeneity (Using texture analysis)	Using texture analysis	Up to 5 years
Change in SUVmax (SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness)	SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Response to therapy based on FDG heterogeneity	Up to 5 years
Response to therapy based on SUVmax	Up to 5 years

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2011
• Primary Completion (Actual): June 2, 2020
• Study Completion (Actual): June 2, 2020

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimate): December 16, 2014

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: 201104322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No