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


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Uterine Cervical Neoplasms

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The primary objective is 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.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Jacqueline Esthappan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

10-0033 / 201109278

NCT ID:

NCT01060033

Start Date:

February 2010

Completion Date:

December 2016

Related Keywords:

  • Uterine Cervical Neoplasms
  • Squamous cell cervical cancer
  • Neoplasms
  • Uterine Cervical Neoplasms

Name

Location

Washington University School of Medicine Saint Louis, Missouri  63110