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MRI and PET Imaging in Predicting Treatment Response in Patients With Stage IB-IVA Cervical Cancer

This study is currently recruiting participants.
Verified June 2017 by University of Washington
Sponsor:
ClinicalTrials.gov Identifier:
NCT01992861
First Posted: November 25, 2013
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
  Purpose
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.

Condition Intervention
Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Cervical Undifferentiated Carcinoma Recurrent Cervical Carcinoma Stage IB2 Cervical Cancer Stage II Cervical Cancer Stage IIA Cervical Cancer Stage IIB Cervical Cancer Stage III Cervical Cancer Stage IIIA Cervical Cancer Stage IIIB Cervical Cancer Stage IVA Cervical Cancer Procedure: Computed Tomography Procedure: Diffusion Weighted Imaging Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Radiation: Fludeoxyglucose F-18 Procedure: Magnetic Resonance Spectroscopic Imaging Procedure: Positron Emission Tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: Up to 5 years ]
  • Distant metastatic rate [ Time Frame: Up to 5 years ]
  • Local control [ Time Frame: Up to 5 years ]
    Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings.

  • Predictive power of the MRI and PET/CT parameters [ Time Frame: Up to 5 years ]
    Hazard ratios will be calculated. Predictive power of the heterogeneity metrics will be compared and ranked with Federation of Gynecology and Obstetrics stage, lymph node status, histology, hemoglobin level, and tumor anatomic volumes. Multivariate predictive algorithms will be derived by synergizing the predictive power of imaging metrics and clinical prognosticators for clinical translation.


Estimated Enrollment: 237
Study Start Date: February 14, 2014
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)
Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo DCE MRI, DW MRI, and MR spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and FDG PET/CT at baseline, 2-2.5 weeks, and 4-5 weeks.
Procedure: Computed Tomography
Undergo FDG PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography
Procedure: Diffusion Weighted Imaging
Undergo DW MRI
Other Names:
  • Diffusion Weighted MRI
  • Diffusion-Weighted Magnetic Resonance Imaging
  • Diffusion-Weighted MR Imaging
  • Diffusion-Weighted MRI
  • DWI
  • DWI MRI
  • DWI-MRI
  • MR Diffusion-Weighted Imaging
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Other Names:
  • DCE MRI
  • DCE-MRI
  • DYNAMIC CONTRAST ENHANCED MRI
Radiation: Fludeoxyglucose F-18
Undergo FDG PET/CT
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18
Procedure: Magnetic Resonance Spectroscopic Imaging
Undergo MR spectroscopy
Other Names:
  • 1H- Nuclear Magnetic Resonance Spectroscopic Imaging
  • 1H-nuclear magnetic resonance spectroscopic imaging
  • Magnetic Resonance Spectroscopy
  • MRS
  • MRS Imaging
  • MRSI
  • Proton Magnetic Resonance Spectroscopic Imaging
Procedure: Positron Emission Tomography
Undergo FDG PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

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 3-6 months for 5 years.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
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): NCT01992861


Locations
United States, Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Aaron H. Wolfson    305-243-4210    awolfson@med.miami.edu   
Principal Investigator: Aaron H. Wolfson         
United States, Georgia
Augusta University Medical Center Withdrawn
Augusta, Georgia, United States, 30912
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Matthew M. Harkenrider    708-216-2575    mharkenrider@lumc.edu   
Principal Investigator: Matthew M. Harkenrider         
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Michael V. Knopp    614-293-8315    Michael.Knopp@osumc.edu   
Principal Investigator: Michael V. Knopp         
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Nina A. Mayr    206-598-4110    ninamayr@uw.edu   
Principal Investigator: Nina A. Mayr         
Canada, Ontario
University of Toronto Recruiting
Toronto, Ontario, Canada, M5S 1A1
Contact: Eric Leung    416-480-5000    eric.leung@sunnybrook.ca   
Principal Investigator: Eric Leung         
Hong Kong
University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong
Contact: Elaine Y. Lee    852 2255 3307    eyplee77@hku.hk   
Principal Investigator: Elaine Y. Lee         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Nina Mayr Fred Hutch/University of Washington Cancer Consortium
  More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01992861     History of Changes
Other Study ID Numbers: 8118
NCI-2013-01935 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
8118 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
R01CA155454 ( U.S. NIH Grant/Contract )
First Submitted: November 5, 2013
First Posted: November 25, 2013
Last Update Posted: June 29, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action