Clinical trial NCT01060033: MRI (Including Spectroscopy and Fat-Saturations and Diffusion-Weighted Imaging) in Cervical Cancer
Official title: A Study of Novel Magnetic Resonance Imaging Sequences for Target Delineation and Prognostication in Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Neoplasms
Keywords: Squamous cell cervical cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2010-02-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: Determine whether MR-DCE or MR-FS or DTI can improve target delineation in primary cervical tumors.
timeFrame: 3 months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jacqueline Esthappan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: