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Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) Cervical Heterogenity Imaging Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Farrokh Dehdashti, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00907140
First received: May 20, 2009
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Cervical Cancer
 Procedure: Positron Emission Tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

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: 25
Study Start Date: August 2008
Estimated Study Completion Date: August 2013
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Chemoradiation therapy 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biopsy-proven cervical cancer. (FIGO stage-Ib2-IVa)
  2. Age ≥ 18
  3. Able to receive chemoradiation therapy with Cisplatin.
  4. Non-pregnant status in women of childbearing potential.
  5. 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.
  6. Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least 1 year.
  7. 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
  8. Able to give informed consent

Exclusion Criteria:

  1. Age < 18
  2. Patients with a known active malignancy other than cervical carcinoma.
  3. Pregnant and breastfeeding patients.
  4. Subjects whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907140

Locations
United States, Missouri
Washington University at St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Perry W Grigsby, M.D. Washington University at St. Louis
  More Information

No publications provided

Responsible Party: Farrokh Dehdashti, Co-Principal Investigator, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00907140     History of Changes
Other Study ID Numbers: 08-0804
Study First Received: May 20, 2009
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Cervical Cancer
Positron Emission Tomography
Fluorodeoxyglucose

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013