Phase I Pilot Study to Evaluate the Prognostic Value of Perfusion CT for Primary Cervical Cancer

October 29, 2018 updated by: Stanford University
The investigators hope to learn whether perfusion CT is a useful way to assess primary cervical tumor microenvironment and whether there is a relationship between pretreatment perfusion CT measurements and primary cervical tumor size, lymph node involvement (as assessed by standard of care pretreatment fludeoxyglucose Positron emission tomography/CT (FDG-PET/CT)), and treatment response (as assessed by standard of care 3-month post-therapy FDG-PET/CT).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 12-15 cervical cancer patients are referred for radiation each year.

Description

Inclusion criteria:

  • >18 years old
  • with biopsy-proven squamous, adenocarcinoma or adenosquamous cervical cancer
  • no history of prior pelvic radiation and should be able to receive chemoradiation
  • non-pregnant women who have not previously undergone a hysterectomy, as that would have removed the cervix.
  • able to give informed consent

Exclusion criteria:

  • Subjects whose tumors are not FDG avid on the pre-therapy PET.
  • Allergy or inability to receive iodinated CT contrast

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure perfusion in primary cervical tumors using perfusion CT.
Time Frame: 3-6 months
Treatment response will be assessed using a post-treatment FDG-PET/CT to evaluate for complete response, persistent disease or new disease. The association between pre-treatment perfusion CT parameters and response on the post-treatment FDG-PET/CT will be analyzed.
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Elizabeth Kidd, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

October 4, 2018

Study Completion (Actual)

October 4, 2018

Study Registration Dates

First Submitted

February 27, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (Estimate)

March 6, 2013

Study Record Updates

Last Update Posted (Actual)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 29, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GYNCVX0003
  • 25821 (Stanford IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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