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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805141
• Other study ID #: GYNCVX0003
• Secondary ID: 25821
• Status: Completed
• Start date: August 2013
• Est. completion date: October 4, 2018

Study information

• Verified date: October 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 4, 2018
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-6 months