MRI and PET Imaging in Predicting Treatment Response in Patients With Stage IB-IVA Cervical Cancer
Study Details
Study Description
Brief Summary
This 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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
PRIMARY OBJECTIVES:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
Procedure: Diffusion Weighted Imaging
Undergo DW MRI
Other Names:
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI
Other Names:
Radiation: Fludeoxyglucose F-18
Undergo FDG PET/CT
Other Names:
Procedure: Magnetic Resonance Spectroscopic Imaging
Undergo MR spectroscopy
Other Names:
Procedure: Positron Emission Tomography
Undergo FDG PET/CT
Other Names:
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Outcome Measures
Primary Outcome Measures
- Disease-free survival [Up to 5 years]
- Distant metastatic rate [Up to 5 years]
- Local control [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 [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
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Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer
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Patients with no prior radiation therapy to the pelvis
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Patients with no contra-indications to magnetic resonance (MR) imaging
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Patients must have adequate renal function: glomerular filtration rate (GFR) > 30 mL/min/1.73 m2; for the test-retest sub-study MRI, patients must have a GFR of > 60 mL/min/1.73m2
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Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
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Patients with small cell/neuroendocrine cervical carcinoma
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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
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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)
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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
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Life expectancy of less than 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 2 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 3 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
| 4 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
| 5 | University of Toronto | Toronto | Ontario | Canada | M5S 1A1 |
| 6 | University of Hong Kong | Hong Kong | Hong Kong |
Sponsors and Collaborators
- University of Washington
- National Cancer Institute (NCI)
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Simon Lo, Fred Hutch/University of Washington Cancer Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8118
- NCI-2013-01935
- 8118
- R01CA155454
- RG3114003