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

Stopped early

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

In brief

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.

Key facts

Study ID

NCT01992861

Run by

University of Washington

People needed

51

Starts

2014-02-14

Expected to finish

2022-01-01

Last updated by the study team

2023-06-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States
• University of Toronto — Toronto, Ontario, Canada
• University of Hong Kong — Hong Kong, Hong Kong

Full record on ClinicalTrials.gov

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