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

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Procedure: Positron Emission Tomography

• Registration Number: NCT00907140
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-21
• Study First Posted: 2009-05-22
• Primary Completion: 2010-11
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemoradiation therapy	Positron Emission Tomography	-

Primary Outcome Measures

Name	Time	Method
The overall goal of this pilot study is to evaluate the change in cervical tumor FDG heterogeneity and SUVmax during chemoradiation.	FDG PET/CT imaging is performed at: Baseline, 2 & 4 weeks of therapy, and 3 months after completing therapy

Secondary Outcome Measures

Name	Time	Method
To correlate changed in FDG heterogeneity and SUVmax with response to therapy.	5 years

Trial Locations

Locations (1)

Washington University at St. Louis; 🇺🇸 Saint Louis, Missouri, United States