Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Varian Medical Systems | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HyperSight cone beam computed tomography (CBCT) scan | Device | HyperSight is a novel onboard imaging platform with a rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for simulation and treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Estimated to be 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Estimated to be 5 days |
Not provided
Inclusion Criteria:
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
Surgically removed or transposed ovaries
Pregnant and/or breastfeeding
Not provided
Not provided
This study will enroll patients at Siteman Cancer Center at Washington University School of Medicine.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Waters, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
Data will be shared if research proposal is submitted and approved by Principal Investigator.
Not provided
Not provided
Email Principal Investigator with research proposal.
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ETHOS 2.0 | Device | 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. |
|
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D012004 | Rectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D012509 | Sarcoma |
| D002583 | Uterine Cervical Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D001005 | Anus Neoplasms |
| D008113 | Liver Neoplasms |
| D013274 | Stomach Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D002577 | Uterine Cervical Diseases |
| D001004 | Anus Diseases |
| D008107 | Liver Diseases |
| D013272 | Stomach Diseases |
| D014571 | Urologic Neoplasms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003947 | Diagnostic Techniques, Radioisotope |
Not provided
Not provided