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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01992861
Other study ID # 8118
Secondary ID NCI-2013-0193581
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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