Anal Cancer, Bladder Cancer, Breast Cancer, Cervix Cancer, Colon Cancer, Gastric Cancer, Head and Neck Cancer, Liver Cancer, Lung Cancer, Rectal Cancer, Sarcoma, Uterine Cancer
Conditions
Keywords
Young onset colorectal cancer, Early onset, Pre-menopausal, Ovarian sparing radiation
Brief summary
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.
Interventions
DEVICEHyperSight cone beam computed tomography (CBCT) scan
HyperSight is a novel onboard imaging platform with a rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for simulation and treatment.
DEVICEETHOS 2.0
ETHOS 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.
Sponsors
Washington University School of Medicine
Varian Medical Systems
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Planning to receive radiation therapy (for any indication) * Ability to understand and willingness to sign an IRB-approved written informed consent document.
Exclusion criteria
* 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 * For patients \> 45 years old, if there is a clinical history of vasomotor symptoms OR irregular periods, then the patient must be excluded. * For patients ≤ 45 years old, if there is a history of vasomotor symptoms consistent with menopause OR irregular menstruation for ≥3 months OR recent changes in their menstrual cycle \> 14 days, then the patient must be excluded. * Surgically removed or transposed ovaries * Pregnant and/or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ovarian visualization | Estimated to be 5 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose | Estimated to be 5 days | 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. |
Countries
United States
Contacts
CONTACTMichael Waters, M.D., Ph.D.
PRINCIPAL_INVESTIGATORMichael Waters, M.D., Ph.D.
Washington University School of Medicine
Outcome results
None listed