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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The overall goal of this pilot study is to evaluate the change in cervical tumor FDG heterogeneity and SUVmax during chemoradiation.

Outcome Time Frame:

FDG PET/CT imaging is performed at: Baseline, 2 & 4 weeks of therapy, and 3 months after completing therapy

Safety Issue:

No

Principal Investigator

Perry W Grigsby, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University at St. Louis

Authority:

United States: Institutional Review Board

Study ID:

08-0804

NCT ID:

NCT00907140

Start Date:

August 2008

Completion Date:

August 2013

Related Keywords:

  • Cervical Cancer
  • Cervical Cancer
  • Positron Emission Tomography
  • Fluorodeoxyglucose
  • Uterine Cervical Neoplasms

Name

Location

Washington University at St. LouisSaint Louis, Missouri  63110