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

Cervical Adenocarcinoma Clinical Trial

Official title:

MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01992861
• Other study ID #: 8118
• Secondary ID: NCI-2013-0193581
• Status: Terminated
• Start date: February 14, 2014
• Est. completion date: January 2022

Study information

• Verified date: June 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Adenosquamous
• Carcinoma, Squamous Cell
• 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
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Computed Tomography
Undergo FDG PET/CT
• Diffusion Weighted Imaging
Undergo DW MRI
• Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE MRI

Radiation:
• Fludeoxyglucose F-18
Undergo FDG PET/CT

Procedure:
• Magnetic Resonance Spectroscopic Imaging
Undergo MR spectroscopy
• Positron Emission Tomography
Undergo FDG PET/CT

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI), National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  Canada,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		Up to 5 years
Primary	Distant metastatic rate		Up to 5 years
Primary	Local control	Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings.	Up to 5 years
Primary	Predictive power of the MRI and PET/CT parameters	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.	Up to 5 years