Back to resultsFludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) Cervical Heterogenity Imaging Study
Primary Purpose
Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positron Emission Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer focused on measuring Cervical Cancer, Positron Emission Tomography, Fluorodeoxyglucose
Eligibility Criteria
Inclusion Criteria:
- Biopsy-proven cervical cancer. (FIGO stage-Ib2-IVa)
- Age ≥ 18
- Able to receive chemoradiation therapy with Cisplatin.
- Non-pregnant status in women of childbearing potential.
- No other active cancer at the time of diagnosis of cervical cancer Patients cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
- Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least 1 year.
- Scheduled to undergo or have already undergone FDG-PET/CT imaging for clinical staging of cervical cancer at Barnes-Jewish Hospital Clinical PET Facility on a Biograph 40 PET/CT scanner
- Able to give informed consent
Exclusion Criteria:
- Age < 18
- Patients with a known active malignancy other than cervical carcinoma.
- Pregnant and breastfeeding patients.
- Subjects whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging
Sites / Locations
- Washington University at St. Louis
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Chemoradiation therapy
Arm Description
Outcomes
Primary Outcome Measures
The overall goal of this pilot study is to evaluate the change in cervical tumor FDG heterogeneity and SUVmax during chemoradiation.
Secondary Outcome Measures
To correlate changed in FDG heterogeneity and SUVmax with response to therapy.
Full Information
NCT ID
NCT00907140
First Posted
May 20, 2009
Last Updated
January 19, 2017
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00907140
Brief Title
Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) Cervical Heterogenity Imaging Study
Official Title
Assessment of Changes in Pattern and Magnitude of Tumor FDG Uptake 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
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Rationale: Diagnostic procedures, such as positron emission tomography (PET) using fluorodeoxyglucose (FDG), may help determine response to standard cancer therapy in patients with cervical cancer
The purpose of this study is to evaluate the change in cervical tumor heterogenity as measured by FDG-PET/CT imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Cervical Cancer, Positron Emission Tomography, Fluorodeoxyglucose
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemoradiation therapy
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Intervention Description
FDG PET/CT imaging is performed at baseline, after 2 and 4 weeks of radiation therapy and approximately 3 months after chemoradiation is completed
Primary Outcome Measure Information:
Title
The overall goal of this pilot study is to evaluate the change in cervical tumor FDG heterogeneity and SUVmax during chemoradiation.
Time Frame
FDG PET/CT imaging is performed at: Baseline, 2 & 4 weeks of therapy, and 3 months after completing therapy
Secondary Outcome Measure Information:
Title
To correlate changed in FDG heterogeneity and SUVmax with response to therapy.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Biopsy-proven cervical cancer. (FIGO stage-Ib2-IVa)
Age ≥ 18
Able to receive chemoradiation therapy with Cisplatin.
Non-pregnant status in women of childbearing potential.
No other active cancer at the time of diagnosis of cervical cancer Patients cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least 1 year.
Scheduled to undergo or have already undergone FDG-PET/CT imaging for clinical staging of cervical cancer at Barnes-Jewish Hospital Clinical PET Facility on a Biograph 40 PET/CT scanner
Able to give informed consent
Exclusion Criteria:
Age < 18
Patients with a known active malignancy other than cervical carcinoma.
Pregnant and breastfeeding patients.
Subjects whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry W Grigsby, M.D.
Organizational Affiliation
Washington University at St. Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University at St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) Cervical Heterogenity Imaging Study
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