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

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ClinicalTrials.gov Identifier: NCT00907140
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Farrokh Dehdashti, Washington University School of Medicine

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.


Condition or disease Intervention/treatment
Cervical Cancer Procedure: Positron Emission Tomography

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Primary Completion Date : November 2010
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Measures :
  1. To correlate changed in FDG heterogeneity and SUVmax with response to therapy. [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by Farrokh Dehdashti, 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