MRI and PET Imaging in Predicting Treatment Response in Patients with Stage IB-IVA Cervical Cancer
18 Years and older, Female
8118 (primary)
NCI-2013-01935
P30CA015704
R01CA155454
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.
Objectives
PRIMARY OBJECTIVES:
I. To assess the value of MRI and PET as a non-invasive predictive assay for therapy outcome in cervical cancer.
II. To refine and advance functional imaging-based Voxel-Histogram (VH) and imaging metrics to characterize tumor heterogeneity and quantify at-risk tumor voxels.
III. To derive novel multivariate predictive algorithms by synergizing the predictive power of imaging metrics and clinical prognosticators for clinical translation.
SPECIFIC AIMS:
I. To develop, test and refine functional MRI parameters of tumor perfusion, diffusion and three-dimensional MRI tumor volume before and during the course of radiation/chemotherapy to characterize tumor heterogeneity.
II. To validate the predictive power of MRI- and PET/CT-based tumor heterogeneity metrics with treatment outcome (tumor control and survival) and to compare the predictive power among the imaging parameters and clinical prognosticators.
III. To collect epidemiology/socio-economic data and to correlate these with the imaging parameters and with clinical outcome.
IV. To perform repeat MRI (as an optional test-retest sub-study) in a subgroup of patients pre-therapy and in early therapy, and to correlate the test and retest MRI findings with tumor recurrence and survival.
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
- 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
- Age >= 18 years
- 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
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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