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

Cervical Cancer Clinical Trial

Official title:

Assessment of Changes in Pattern and Magnitude of Tumor FDG Uptake During Chemoradiation as a Predictor of Response to Concurrent Radiation Therapy and Chemotherapy in Patients With Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907140
• Other study ID #: 08-0804
• Status: Completed
• Phase: N/A
• First received: May 20, 2009
• Last updated: January 19, 2017
• Start date: August 2008
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2016
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Washington University at St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To correlate changed in FDG heterogeneity and SUVmax with response to therapy.		5 years