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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
November 5, 2013
November 25, 2013
June 29, 2017
February 14, 2014
September 2021   (Final data collection date for primary outcome measure)
  • 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.
  • 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 (FIGO) 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.
  • Local control [ Time Frame: Up to 5 years ]
    Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings
  • Distant metastatic rate [ Time Frame: Up to 5 years ]
  • Disease-free survival [ Time Frame: Up to 5 years ]
Complete list of historical versions of study NCT01992861 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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MRI and PET Imaging in Predicting Treatment Response in Patients With Stage IB-IVA Cervical Cancer
MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • 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
    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
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.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
237
Not Provided
September 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Canada,   Hong Kong,   United States
 
 
NCT01992861
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 )
No
Not Provided
Not Provided
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Nina Mayr Fred Hutch/University of Washington Cancer Consortium
University of Washington
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP