MRI and PET Imaging in Predicting Treatment Response in Patients With Stage IB-IVA Cervical Cancer
Conditions
Cervical Adenocarcinoma - Cervical Adenosquamous Carcinoma - Cervical Squamous Cell Carcinoma - Cervical Undifferentiated Carcinoma - Recurrent Cervical Carcinoma - Stage IB Cervical Cancer - Stage IIA Cervical Cancer - Stage IIB Cervical Cancer - Stage IIIA Cervical Cancer - Stage IIIB Cervical Cancer - Stage IVA Cervical Cancer
Conditions: official terms
Adenocarcinoma - Carcinoma - Carcinoma, Adenosquamous - Carcinoma, Squamous Cell - Uterine Cervical Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Computed Tomography Type: Procedure
Name: Diffusion Weighted Imaging Type: Procedure
Name: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Type: Procedure
Name: Fludeoxyglucose F-18 Type: Radiation
Name: Magnetic Resonance Spectroscopic Imaging Type: Procedure
Name: Positron Emission Tomography Type: Procedure
Overall Status
Recruiting
Summary
This clinical trial studies magnetic resonance imaging (MRI) and positron emission tomography (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. PET is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Comparing results of diagnostic procedures, such as MRI and PET, done before, during and after radiation and chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Detailed Description
PRIMARY OBJECTIVES:

I. To assess the value of MRI and PET as a non-invasive predictive assay for therapy outcome in cervical cancer.

OUTLINE:

Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo dynamic contrast-enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and magnetic resonance (MR) spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and fludeoxyglucose F 18 (FDG) PET/computed tomography (CT) at baseline, 2-2.5 weeks, and 4-5 weeks.

After completion of study, patients are followed up at least every 4 months for 2 years and then at least every 6 months for 3 years.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Patients must have histologically confirmed stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excluding small cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervical cancer with curative intent

- Surgical staging with retroperitoneal staging and lymphadenectomy is permitted

- Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer

- Patients with no prior radiation therapy to the pelvis

- Patients with no contra-indications to magnetic resonance (MR) imaging as stated in the section exclusion criteria

- Patients must have adequate renal function: glomerular filtration rate (GFR) > 30 mL/min/1.73 m^2; for the test-retest sub-study MRI, patients must have a GFR of > 60 mL/min/1.73m^2

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients with small cell/neuroendocrine cervical carcinoma

- Patients who have received any prior pelvic radiation therapy in the area of the tumor that precludes the delivery of a curative dose of pelvic radiation

- Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR < 30)

- Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-up

- Life expectancy of less than 6 months
Locations
Georgia Regents University Medical Center
Augusta, Georgia, United States
Status: Recruiting
Contact: Feng-Ming (Spring) P. Kong - 706-721-1663 - cancer@georgiahealth.edu
Ohio State University
Columbus, Ohio, United States
Status: Recruiting
Contact: Michael V. Knopp - 614-293-8315
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Status: Recruiting
Contact: Nina A. Mayr - 206-598-4110
Start Date
February 2014
Sponsors
University of Washington
Source
University of Washington
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page