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

Terminated

• Conditions: Cervical Undifferentiated Carcinoma; Stage IIIB Cervical Cancer; Cervical Adenosquamous Carcinoma; Stage III Cervical Cancer; Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Stage II Cervical Cancer; Cervical Adenocarcinoma; Stage IB2 Cervical Cancer; Stage IIB Cervical Cancer; Recurrent Cervical Carcinoma
• Interventions: Procedure: Computed Tomography; Procedure: Diffusion Weighted Imaging; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Radiation: Fludeoxyglucose F-18; Procedure: Magnetic Resonance Spectroscopic Imaging; Procedure: Positron Emission Tomography

• Registration Number: NCT01992861
• Lead Sponsor: University of Washington

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Study Start: 2014-02-14
• Primary Completion: 2022-01
• Study Completion: 2022-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)	Dynamic Contrast-Enhanced Magnetic Resonance Imaging	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.
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)	Fludeoxyglucose F-18	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.
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)	Diffusion Weighted Imaging	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.
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)	Computed Tomography	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.
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)	Positron Emission Tomography	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.
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)	Magnetic Resonance Spectroscopic Imaging	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.

Primary Outcome Measures

Name	Time	Method
Predictive power of the MRI and PET/CT parameters	Up to 5 years	Hazard ratios will be calculated. Predictive power of the heterogeneity metrics will be compared and ranked with Federation of Gynecology and Obstetrics stage, lymph node status, histology, hemoglobin level, and tumor anatomic volumes. Multivariate predictive algorithms will be derived by synergizing the predictive power of imaging metrics and clinical prognosticators for clinical translation.
Disease-free survival	Up to 5 years
Distant metastatic rate	Up to 5 years
Local control	Up to 5 years	Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings.

Trial Locations

Locations (6)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center; 🇺🇸 Miami, Florida, United States

University of Toronto; 🇨🇦 Toronto, Ontario, Canada

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States

University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong