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

ID: NCT02317302
Status: Active, not recruiting
Phase: Phase 1
Start Date: June 28, 2011
First Submitted: December 10, 2014
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Cervical Cancer, Uterine Cervical Cancer, Uterine Cervical Neoplasms
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Cervical Cancer

Uterine Cervical Cancer

Uterine Cervical Neoplasms

Device: FDG-PET/MR
Other Names
PET/MR
Device: FDG-PET/CT
Other Names
PET/CT
Phase 1

Tracking Information

First Submitted DateDecember 10, 2014
Last Update Posted DateFebruary 22, 2018
Actual Start DateJune 28, 2011
Anticipated Completion DateDecember 31, 2020
Actual Primary Completion DateDecember 31, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Change in SUVmax (SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness) [Time Frame: Up to 5 years]

    SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness.

  • Change in FDG heterogeneity (Using texture analysis) [Time Frame: Up to 5 years]

    Using texture analysis

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Response to therapy based on FDG heterogeneity [Time Frame: Up to 5 years]

  • Response to therapy based on SUVmax [Time Frame: Up to 5 years]

Original Secondary Outcome Measures

Not Available

Study Design

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

Detailed Description

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
48
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Screening
Conditions
Cervical Cancer
Uterine Cervical Cancer
Uterine Cervical Neoplasms
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Device: FDG-PET/MR

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

Other Names
PET/CT
Study Groups/Cohorts
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.

Study Arms
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

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/CT

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
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/CT

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment48
Completion DateDecember 31, 2020
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.
GenderFemale
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02317302
Other Study ID Numbers
201104322
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Perry Grigsby, M.D.
Washington University School of Medicine