FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cervical Cancer, Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/15/2018 |
| Start Date: | June 28, 2011 |
| End Date: | February 6, 2021 |
FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response to Concurrent Radiation Therapy and Chemotherapy in Patients With Cervical Cancer
In this study, 50 evaluable patients will undergo one FDG-PET study during their
chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment
clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax,
FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and
heterogeneity during treatment will aid in better understanding the role of these biological
parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging,
have evaluated changes in the cervical tumor volume during treatment. The investigators
expect there will be variation in how cervical tumors shrink and change during chemoradiation
and therefore we are going to use multiple measures in addition to tumor volume to evaluate
cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who
are at higher risk for persistent disease following chemoradiation would allow for future
studies where these high risk patients could be specifically targeted with more aggressive
therapy.
chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment
clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax,
FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and
heterogeneity during treatment will aid in better understanding the role of these biological
parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging,
have evaluated changes in the cervical tumor volume during treatment. The investigators
expect there will be variation in how cervical tumors shrink and change during chemoradiation
and therefore we are going to use multiple measures in addition to tumor volume to evaluate
cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who
are at higher risk for persistent disease following chemoradiation would allow for future
studies where these high risk patients could be specifically targeted with more aggressive
therapy.
Inclusion Criteria:
- Patient must have biopsy-proven cervical cancer (FIGO stage-Ib2-IVb).
- Patient must be at least18 years of age.
- Patient must be planning to receive chemoradiation therapy with cisplatin.
- Patient must have non-pregnant status if a female of childbearing potential. Women who
have had a tubal ligation at least 12 months prior to study entry or a hysterectomy
will be considered NOT of childbearing potential. Postmenopausal women must have been
amenorrheic for at least 12 consecutive months to be considered NOT of childbearing
potential.
- Patient may have distant metastatic disease provided the estimated survival is at
least 1 year.
- Patient's tumor(s) must be FDG avid on baseline standard of care FDG-PET/CT or PET/MR
imaging that was performed at Barnes-Jewish Hospital Clinical PET Facility.
- Patient must be able and willing to give informed consent.
- If the patient will be scanned on the PET/MR for the mid-treatment scan, they must be
determined to be safe for exposure to the magnetic field. This will be determined the
day of imaging by the technologist with the use of a screening form. If a patient is
not safe for the PET/MR scanner, their mid-treatment images will occur on the PET/CT
scanner in the Center for Clinical Imaging Research.
Exclusion Criteria:
- Patient must have no other active cancer at the time of diagnosis of cervical cancer.
- Patient cannot have received treatment for any malignancy, with the exception of
non-melanoma skin cancer, in the past 5 years.
- Patient must not be an uncontrolled diabetic with a glucose of ≥ 200mg/dl at the time
of PET imaging.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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