Back to resultsFDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer
Primary Purpose
Cervical Cancer, Uterine Cervical Cancer, Uterine Cervical Neoplasms
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FDG-PET/MR
FDG-PET/CT
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer
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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FDG-PET/CT or FDG-PET/MR
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in FDG heterogeneity (Using texture analysis)
Using texture analysis
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.
Secondary Outcome Measures
Response to therapy based on FDG heterogeneity
Response to therapy based on SUVmax
Full Information
NCT ID
NCT02317302
First Posted
December 10, 2014
Last Updated
June 8, 2020
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02317302
Brief Title
FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer
Official Title
FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response to Concurrent Radiation Therapy and Chemotherapy in Patients With Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Insufficient funding
Study Start Date
June 28, 2011 (Actual)
Primary Completion Date
June 2, 2020 (Actual)
Study Completion Date
June 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Uterine Cervical Cancer, Uterine Cervical Neoplasms
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FDG-PET/CT or FDG-PET/MR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FDG-PET/MR
Other Intervention Name(s)
PET/MR
Intervention Type
Device
Intervention Name(s)
FDG-PET/CT
Other Intervention Name(s)
PET/CT
Primary Outcome Measure Information:
Title
Change in FDG heterogeneity (Using texture analysis)
Description
Using texture analysis
Time Frame
Up to 5 years
Title
Change in SUVmax (SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness)
Description
SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Response to therapy based on FDG heterogeneity
Time Frame
Up to 5 years
Title
Response to therapy based on SUVmax
Time Frame
Up to 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry Grigsby, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer
We'll reach out to this number within 24 hrs