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

NCT ID: NCT01805141

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2018-10-04

Brief Summary

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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).

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Kidd, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32251757 (View on PubMed)

Other Identifiers

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25821

Identifier Type: OTHER

Identifier Source: secondary_id

GYNCVX0003

Identifier Type: -

Identifier Source: org_study_id

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