MRI (Including Spectroscopy and Fat-Saturations and Diffusion-Weighted Imaging) in Cervical Cancer

Uterine Cervical Neoplasms Clinical Trial

— MRI  

Official title:

A Study of Novel Magnetic Resonance Imaging Sequences for Target Delineation and Prognostication in Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060033
• Other study ID #: 10-0033 / 201109278
• Status: Completed
• Phase: N/A
• First received: January 28, 2010
• Last updated: April 12, 2017
• Start date: November 2010
• Est. completion date: August 2014

Study information

• Verified date: April 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To detect differences in MR spectroscopy, diffusion weighted MR, diffusion tensor imaging (DTI) or dynamic contrast enhancement (DCE) MR imaging between primary cervical tumors and normal cervical tissue.

Description:

At our institution, all patients receiving external beam and/or brachytherapy as part of the treatment of primary cervical cancer receive CT, PET, and MRI simulation scans as standard of care. Brachytherapy patients also receive weekly T1/T2 weighted MR simulation scans as part of their treatment planning.

We propose the use of additional MR sequences to the standard T1/T2 weighted MR simulation scans. The data obtained from these additional sequences will be used for improving tumor delineation and obtaining prognostic information.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have biopsy-proven newly diagnosed squamous cell cervical cancer (FIGO clinical stages IB2-IVA).

• Patients must be = 18 years of age.

• Patients must be able to receive standard radiation therapy (external beam radiation and brachytherapy) with or without chemotherapy.

• Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least one year.

• Patients must be scheduled to undergo or have already undergone FDG-PET/CT imaging for clinical staging cervical cancer at Barnes-Jewish Hospital Clinical PET facility on the Siemens Biograph 40 True Point Tomograph Scanner or elsewhere in the WUSM Nuclear Medicine department using the quality controls instituted by Nuclear Medicine.

• Patients must be able to give informed consent.

Exclusion Criteria:

• Patients with another known active malignancy.

• Patients who have received treatment for any malignancy (with the exception of non-melanoma skin cancer) in the past 5 years.

• Pregnant or breastfeeding patients.

• Patients whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging.

• Patients with contraindications to MRI scanning.

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Intervention

Device:
• MR Spectroscopy

• Fat-Saturation and Diffusion-Weighted Imaging

• Dynamic Contrast Enhancement MRI (MR-DCE)

• Diffusion Tensor Imaging (DTI)

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in MR spectroscopy, diffusion weighted MR, diffusion tensor imaging (DTI) or dynamic contrast enhancement (DCE) MR imaging between primary cervical tumors and normal cervical tissue.		3 months
Secondary	Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors.		3 months

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine