Female patients with early onset (\<50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, which often requires pelvic radiation; many of these patients are premenopausal and at a high risk of premature ovarian failure from radiotherapy. Premature ovarian failure carries significant cardiac, musculoskeletal, sexual, and psychosocial morbidity. Ovarian transposition carries variable success rates, is not readily accessible to the general population, and can still be at risk of clinically significant radiotherapy doses. There is an unmet need for innovative techniques to protect ovarian function.
Biologic female
Age between 18 and 50 years old (inclusive)
Clinically premenopausal (defined as having active, regular menstruation without vasomotor symptoms)
At least one of two ovaries readily visualized on diagnostic CT or MR imaging as confirmed by radiologist
Prior pelvic radiation
Prior cancer therapies that are known to impact ovarian function
Prior diagnosis of ovarian insufficiency/failure or menopause
Clinically peri- or post-menopausal
This study will enroll patients at Siteman Cancer Center at Washington University School of Medicine.
Cohort
Prospective
HyperSight cone beam computed tomography (CBCT) scan
DeviceHyperSight is a novel onboard imaging platform with a rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for simulation and treatment.
ETHOS 2.0
DeviceETHOS 2.0, an artificial intelligence treatment planning system, will be utilized in an emulator to create SCRT plans to determine the feasibility of clinically significant ovarian dose reductions in-silico.
Incidence of ovarian visualization
Defined as being able to delineate at least one ovary (if only one is visible, must be the same ovary) for ≥60% of CBCT sessions per patient.
Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose
Defined as maintaining a cumulative \>95% coverage of planned tumor volume (PTV) with 95% of the prescription dose (25 Gy/5 fx) while delivering no more 6 Gy to the ovaries per patient. If only one ovary can meet constraints it must be the same ovary over all fractions.
Click on the lead sponsor to view all of their trials.
Washington University School of Medicine
Lead sponsor
Varian Medical Systems
Collaborator
