Trial record 1 of 7 for:
Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) Cervical Heterogenity Imaging Study
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Farrokh Dehdashti, Washington University School of Medicine
First received: May 20, 2009
Last updated: February 5, 2014
Last verified: February 2014
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.
Procedure: Positron Emission Tomography
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||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
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To correlate changed in FDG heterogeneity and SUVmax with response to therapy. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||November 2010 (Final data collection date for primary outcome measure)
Procedure: Positron Emission Tomography
FDG PET/CT imaging is performed at baseline, after 2 and 4 weeks of radiation therapy and approximately 3 months after chemoradiation is completed
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00907140
|Washington University at St. Louis
|Saint Louis, Missouri, United States, 63110 |
Washington University School of Medicine
||Perry W Grigsby, M.D.
||Washington University at St. Louis
No publications provided
||Farrokh Dehdashti, Co-Principal Investigator, Washington University School of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 20, 2009
||February 5, 2014
||United States: Institutional Review Board
Keywords provided by Washington University School of Medicine:
Positron Emission Tomography
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
Uterine Cervical Neoplasms
Genital Neoplasms, Female
Neoplasms by Site
Uterine Cervical Diseases
Genital Diseases, Female