Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) Cervical Heterogenity Imaging Study
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
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 20, 2009
CompletedFirst Posted
Study publicly available on registry
May 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 20, 2017
January 1, 2017
2.3 years
May 20, 2009
January 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The overall goal of this pilot study is to evaluate the change in cervical tumor FDG heterogeneity and SUVmax during chemoradiation.
FDG PET/CT imaging is performed at: Baseline, 2 & 4 weeks of therapy, and 3 months after completing therapy
Secondary Outcomes (1)
To correlate changed in FDG heterogeneity and SUVmax with response to therapy.
5 years
Study Arms (1)
Chemoradiation therapy
OTHERInterventions
FDG PET/CT imaging is performed at baseline, after 2 and 4 weeks of radiation therapy and approximately 3 months after chemoradiation is completed
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University at St. Louis
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Perry W Grigsby, M.D.
Washington University at St. Louis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Principal Investigator
Study Record Dates
First Submitted
May 20, 2009
First Posted
May 22, 2009
Study Start
August 1, 2008
Primary Completion
November 1, 2010
Study Completion
December 1, 2016
Last Updated
January 20, 2017
Record last verified: 2017-01