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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01805141
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief Summary:
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).

Condition or disease
Cervical Cancer

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Phase I Pilot Study to Evaluate the Prognostic Value of Perfusion CT for Primary Cervical Cancer
Study Start Date : August 2013
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 12-15 cervical cancer patients are referred for radiation each year.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805141


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Elizabeth Kidd, MD Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01805141    
Other Study ID Numbers: GYNCVX0003
25821 ( Other Identifier: Stanford IRB )
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stanford University:
Cervix Uteri
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female