FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer

NCT02317302TerminatedPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Washington University School of Medicine

Enrollment

48

Start Date

2011-06-28

Completion Date

2020-06-02

Study Type

INTERVENTIONAL

Official Title

FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response to Concurrent Radiation Therapy and Chemotherapy in Patients With Cervical Cancer

Interventions

FDG-PET/MRFDG-PET/CT

Conditions

Cervical CancerUterine Cervical CancerUterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Change in FDG heterogeneity (Using texture analysis)

Using texture analysis

Time frame: Up to 5 years

Change in SUVmax (SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness)

SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness.

Time frame: Up to 5 years

Secondary Outcomes

Response to therapy based on FDG heterogeneity

Time frame: Up to 5 years

Response to therapy based on SUVmax

Time frame: Up to 5 years

Locations

Washington University School of Medicine, St Louis, United States