This trial is active, not recruiting.

Condition cervical cancer
Treatment positron emission tomography
Sponsor Washington University School of Medicine
Start date August 2008
End date November 2010
Trial size 25 participants
Trial identifier NCT00907140, 08-0804


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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

Primary Outcomes

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

Secondary Outcomes

To correlate changed in FDG heterogeneity and SUVmax with response to therapy.
time frame: 5 years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Principal investigator Perry W Grigsby, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.