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

NCT01805141 | Completed

• 2 other identifiers: GYNCVX000325821
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Cervical Cancer

Keywords

Cervix Uteri

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \>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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Capaldi DPI, Hristov DH, Kidd EA. Parametric Response Mapping of Coregistered Positron Emission Tomography and Dynamic Contrast Enhanced Computed Tomography to Identify Radioresistant Subvolumes in Locally Advanced Cervical Cancer. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):756-765. doi: 10.1016/j.ijrobp.2020.03.023. Epub 2020 Apr 3.

  PMID: 32251757 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Elizabeth Kidd, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 6, 2013
• Study Start: August 1, 2013
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)