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

University of Washington

Status: Terminated

Conditions: Stage IVA Cervical Cancer; Cervical Adenocarcinoma; Stage IIIB Cervical Cancer; Recurrent Cervical Carcinoma; Cervical Adenosquamous Carcinoma; Cervical Undifferentiated Carcinoma; Stage III Cervical Cancer; Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Stage IB2 Cervical Cancer; Stage IIB Cervical Cancer; Stage IIA Cervical Cancer; Stage IIIA Cervical Cancer; Stage II Cervical Cancer

Treatments: Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Procedure: Computed Tomography; Procedure: Magnetic Resonance Spectroscopic Imaging; Procedure: Positron Emission Tomography; Radiation: Fludeoxyglucose F-18; Procedure: Diffusion Weighted Imaging

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01992861

8118 (Other Identifier)

R01CA155454 (U.S. NIH Grant/Contract)

RG3114003 (Other Identifier)

NCI-2013-01935 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

51 participants in 1 patient group

Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)

Description:

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.

Treatment:

Procedure: Diffusion Weighted Imaging

Radiation: Fludeoxyglucose F-18

Procedure: Positron Emission Tomography

Procedure: Magnetic Resonance Spectroscopic Imaging

Procedure: Computed Tomography

Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging