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

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.

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