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

NCT01060033 | Completed

• 1 other identifier: 10-0033 / 201109278
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterine Cervical Neoplasms

Keywords

Squamous cell cervical cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors.

  3 months

Study Arms (1)

Arm 1

OTHER

* Clinical T1/T2-weighted MRI sequence per standard of care before treatment, during treatment per standard protocol, and at 3 months. * Patients may have one or all of the following sequences in addition to the standard MRI imaging: * MR Spectroscopy * Fat-saturation and Diffusion-Weighted Imaging * Dynamic Contrast Enhancement MRI (MR-DCE) * Diffusion Tensor Imaging (DTI)

Device: MR Spectroscopy; Device: Fat-Saturation and Diffusion-Weighted Imaging; Device: Dynamic Contrast Enhancement MRI (MR-DCE); Device: Diffusion Tensor Imaging (DTI)

Interventions

MR Spectroscopy DEVICE

Arm 1

Fat-Saturation and Diffusion-Weighted Imaging DEVICE

Arm 1

Dynamic Contrast Enhancement MRI (MR-DCE) DEVICE

Arm 1

Diffusion Tensor Imaging (DTI) DEVICE

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Diffusion Magnetic Resonance Imaging; Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Neuroimaging; Diagnostic Techniques, Neurological

Study Officials

• Jacqueline Esthappan, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: February 1, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

US (1)