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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01992861
First received: November 5, 2013
Last updated: March 27, 2014
Last verified: March 2014
  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. Comparing results of diagnostic procedures 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 Cell Carcinoma
Cervical Squamous Cell Carcinoma
Recurrent Cervical Cancer
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage IIIA Cervical Cancer
Stage IIIB Cervical Cancer
Stage IVA Cervical Cancer
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: diffusion-weighted magnetic resonance imaging
Procedure: magnetic resonance spectroscopic imaging
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography
Procedure: computed tomography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Predictive power of the MRI and PET/CT parameters [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings

  • Distant metastatic rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 237
Study Start Date: February 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: dynamic contrast-enhanced magnetic resonance imaging
Undergo DCE MRI
Other Name: DCE-MRI
Procedure: diffusion-weighted magnetic resonance imaging
Undergo DW MRI
Other Name: diffusion-weighted MRI
Procedure: magnetic resonance spectroscopic imaging
Undergo MR spectroscopy
Other Names:
  • 1H-nuclear magnetic resonance spectroscopic imaging
  • Proton Magnetic Resonance Spectroscopic Imaging
Radiation: fludeoxyglucose F 18
Undergo FDG PET/CT
Other Names:
  • 18FDG
  • FDG
Procedure: positron emission tomography
Undergo FDG PET/CT
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo FDG PET/CT
Other Name: tomography, computed

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992861

Locations
United States, North Carolina
Eastern Carolina University Not yet recruiting
Greenville, North Carolina, United States, 27858
Contact: Zhibin Huang    252-744-3768      
Principal Investigator: Zhibin Huang         
United States, Ohio
Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: William T. Yuh    614-293-5166      
Principal Investigator: William T. Yuh         
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Nina A. Mayr    206-598-4110      
Principal Investigator: Nina A. Mayr         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Nina Mayr Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01992861     History of Changes
Other Study ID Numbers: 8118, NCI-2013-01935, 8118, P30CA015704, R01CA155454
Study First Received: November 5, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Squamous Cell
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
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014