MRI and PET Imaging in Predicting Treatment Response in Patients With Stage IB-IVA Cervical Cancer

Last updated: June 22, 2023
Sponsor: University of Washington
Overall Status: Terminated

Phase

N/A

Condition

Lung Cancer

Carcinoma

Cervical Cancer

Treatment

Computed Tomography

Diffusion Weighted Imaging

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Clinical Study ID

NCT01992861
8118
NCI-2013-01935
R01CA155454
RG3114003
8118
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must have histologically confirmed stage IB2-IVA epithelial carcinoma of thecervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excludingsmall cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervicalcancer with curative intent
  • Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
  • Patients who will undergo standard radiation therapy with concurrent cisplatin-basedchemotherapy 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) > 30mL/min/1.73 m^2; for the test-retest sub-study MRI, patients must have a GFR of > 60mL/min/1.73m^2
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion

Exclusion Criteria:

  • Patients with small cell/neuroendocrine cervical carcinoma
  • Patients who have received any prior pelvic radiation therapy in the area of the tumorthat precludes the delivery of a curative dose of pelvic radiation
  • Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysmclips, 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, wouldprevent completion of treatment, completion of the study protocol, or interfere withfollow-up
  • Life expectancy of less than 6 months

Study Design

Total Participants: 51
Treatment Group(s): 6
Primary Treatment: Computed Tomography
Phase:
Study Start date:
February 14, 2014
Estimated Completion Date:
January 31, 2022

Study 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.

Connect with a study center

  • University of Toronto

    Toronto, Ontario M5S 1A1
    Canada

    Site Not Available

  • University of Hong Kong

    Hong Kong,
    Hong Kong

    Site Not Available

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington 98109
    United States

    Site Not Available

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