Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02317302
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02317302
Study Brief:
Protocol Section:
NCT02317302