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

Active:	No
Cancer Type:	Cervical Cancer	NCT ID:	NCT01992861
Trial Phases:		Protocol IDs:	8118 (primary) NCI-2013-01935 P30CA015704 R01CA155454
Eligibility:	18 Years and older, Female	Study Type:	Diagnostic
Study Sponsor:	Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
NCI Full Details:	http://clinicaltrials.gov/show/NCT01992861

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.

**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... Click here to learn more about clinical trials.