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

Study Overview
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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.

Official Title
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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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-proven cervical cancer. (FIGO stage-Ib2-IVa) Age ≥ 18 Able to receive chemoradiation therapy with Cisplatin. Non-pregnant status in women of childbearing potential. 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. Patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least 1 year. 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 Able to give informed consent Exclusion Criteria: Age < 18 Patients with a known active malignancy other than cervical carcinoma. Pregnant and breastfeeding patients. Subjects whose tumors are not FDG avid on baseline standard of care FDG-PET/CT imaging

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Chemoradiation therapy<br> | Procedure: Positron Emission Tomography<br>* FDG PET/CT imaging is performed at baseline, after 2 and 4 weeks of radiation therapy and approximately 3 months after chemoradiation is completed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate changed in FDG heterogeneity and SUVmax with response to therapy. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Cancer, Positron Emission Tomography, Fluorodeoxyglucose