Fludeoxyglucose (FDG) Positron Emission Tomography/Computed Tomography (PET/CT) Cervical Heterogenity Imaging Study

NCT ID: NCT00907140

Last Updated: 2017-01-20

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

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2016-12-31

Brief Summary

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Rationale: Diagnostic procedures, such as positron emission tomography (PET) using fluorodeoxyglucose (FDG), may help determine response to standard cancer therapy in patients with cervical cancer

The purpose of this study is to evaluate the change in cervical tumor heterogenity as measured by FDG-PET/CT imaging.

Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Chemoradiation therapy

Group Type OTHER

Positron Emission Tomography

Intervention Type PROCEDURE

FDG PET/CT imaging is performed at baseline, after 2 and 4 weeks of radiation therapy and approximately 3 months after chemoradiation is completed

Interventions

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Positron Emission Tomography

FDG PET/CT imaging is performed at baseline, after 2 and 4 weeks of radiation therapy and approximately 3 months after chemoradiation is completed

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Biopsy-proven cervical cancer. (FIGO stage-Ib2-IVa)
2. Age ≥ 18
3. Able to receive chemoradiation therapy with Cisplatin.
4. Non-pregnant status in women of childbearing potential.
5. No other active cancer at the time of diagnosis of cervical cancer Patients cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
6. Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least 1 year.
7. Scheduled to undergo or have already undergone FDG-PET/CT imaging for clinical staging of cervical cancer at Barnes-Jewish Hospital Clinical PET Facility on a Biograph 40 PET/CT scanner
8. Able to give informed consent

Exclusion Criteria

1. Age \< 18
2. Patients with a known active malignancy other than cervical carcinoma.
3. Pregnant and breastfeeding patients.
4. Subjects whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Farrokh Dehdashti

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Perry W Grigsby, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University at St. Louis

Locations

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Washington University at St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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08-0804

Identifier Type: -

Identifier Source: org_study_id

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