Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y): an In-Silico Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Incidence of ovarian visualization
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Ovarian-Sparing Adaptive Radiotherapy
A 25 Gy / 5 fx rectal plan for all patients, irrespective of their primary malignancy, will be created as per institutional standards. Patients may undergo treatment on any radiation therapy machine but will have their pelvis images on a HyperSight CBCT machine after consent while they receive their treatment. In general, patients will be imaged with 2 CBCTs approximately 10 minutes apart, each imaging session / day. However, only one CBCT per treatment session is required, and a patient may have between 1 to 10 scans total throughout 1 to 5 imaging sessions. In general, if ovaries are well visualized then only 1 or 2 imaging sessions will be completed.
干预措施: ETHOS 2.0 (Device)
Ovarian-Sparing Adaptive Radiotherapy
A 25 Gy / 5 fx rectal plan for all patients, irrespective of their primary malignancy, will be created as per institutional standards. Patients may undergo treatment on any radiation therapy machine but will have their pelvis images on a HyperSight CBCT machine after consent while they receive their treatment. In general, patients will be imaged with 2 CBCTs approximately 10 minutes apart, each imaging session / day. However, only one CBCT per treatment session is required, and a patient may have between 1 to 10 scans total throughout 1 to 5 imaging sessions. In general, if ovaries are well visualized then only 1 or 2 imaging sessions will be completed.
干预措施: HyperSight cone beam computed tomography (CBCT) scan (Device)
结局指标
主要结局
Incidence of ovarian visualization
时间窗: 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.
次要结局
- Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose(Estimated to be 5 days)