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

Stanford University24 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Cervical Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

Measure perfusion in primary cervical tumors using perfusion CT.

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.

Time frame: 3-6 months

Data from ClinicalTrials.gov

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